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SEC Company Response from IMAGING DIAGNOSTIC SYSTEMS — Jun 7, 2005

IMAGING DIAGNOSTIC SYSTEMS INC /FL/ (CIK 0000790652)
Date: June 7, 2005 · CIK: 0000790652 · Accession: 0000790652-05-000013

AI Filing Summary & Sentiment

File numbers found in text: 000-26028

Referenced dates: April 7, 2005

Date
June 7, 2005
Author
Not clearly detected
Form
CORRESP
Company
IMAGING DIAGNOSTIC SYSTEMS INC /FL/ (CIK 0000790652)

Letter

June 7, 2005 VIA EDGAR AND UPS RED --------------------- Gary Todd, Reviewing Accountant Securities and Exchange Commission Division of Corporate Finance Mail Stop 03-06 450 Fifth Street, N.W. Washington, D.C. 20549-0306

Re: Imaging Diagnostic Systems, Inc. Form 10-K for the Fiscal Year Ended June 30, 2004 Filed September 17, 2004 Quarterly Report on Form 10-Q for the period ended December 31, 2004 File No.: 000-26028

Dear Mr. Todd:

In connection with the review of the above-captioned Form 10-K and Form 10-Q for Imaging Diagnostic Systems, Inc. (the "Company"), we are responding to your comments set forth in your letter dated April 7, 2005, to Allan L. Schwartz, Executive Vice President and Chief Financial Officer of the Company, which was received in our office by Fax on April 8, 2005. We have enclosed the following documents to assist you in expediting our review:

1. This cover letter 2. Original letter containing supplemental information - Confidential Version 3. Copy of letter containing supplemental information - Redacted Version 4. Copy of FOIA Confidential Treatment Request Letter 5. Marked copy of Amendment No. 1 to our Form 10-K showing changes from their filing date (without exhibits) 6. Marked copy of Amendment No. 1 to our Form 10-Q showing changes from their filing date (without exhibits)

This cover letter, the redacted supplemental information letter and our amended Form 10-K and Form 10-Q have been filed with the Commission via EDGAR earlier today.

Form 10-K for the Fiscal Year Ended June 30, 2004

Item 7. Management's Discussion and Analysis of Financial Condition and Results ----------------------------------------------------------------------- of Operations - Page 27 -----------------------

Results of Operations - Page 27 -------------------------------

<PAGE>

Securities and Exchange Commission Division of Corporate Finance June 7, 2005 Page 2

Balance Sheet Data - Page 28 ----------------------------

1. We have revised our MD&A to expand our discussion and quantify significant factors where the result in each line item has been impacted by more than one factor.

2. We have revised our MD&A to more fully describe our inventory, which consists of raw materials, work in process and finished goods. We have also revised Note 5, "Inventories," to conform to these three categories. Our raw materials consist of parts, most of which are not readily available because of long lead times from manufacturers or distributors, and custom fabricated parts and assemblies, which always have a long lead-time. Examples of some of our costly parts and assemblies which have long-lead times are laser diodes, custom aluminum frames, precision machined parts, custom fiberglass enclosures, and custom printed circuit boards.

As a medical device manufacturer, we must adhere to very high standards of control and quality assurance. Our sole product, the CTLM(R), is a CT scanner, which, when completed, must undergo extensive in-house inspection and testing. We have revised our disclosure to include "completed units under testing" as a component of work in process. Once inspection and testing of a CTLM(R) has been completed, it will be deemed finished goods.

All of the current inventory consisting of raw materials and work in process will, during the normal course of manufacturing the CTLM(R), result in finished goods available for sale. We are in the process of international globalization and have appointed distributors to sell our product and have placed systems for demonstration and clinical collaboration to create awareness of our product. All of these systems will be available for sale and the carrying costs of these systems have been and will continue to be written down to the lower of cost or market on a quarterly basis. We expect to recover our investment because the CTLM(R) is new technology and is currently the only CT scanner dedicated to breast imaging capable of producing three dimensional images using a laser beam instead of ionizing X-ray. Our international marketing program is underway and we have reported the sale of three CTLM(R) systems in the quarter ending March 31, 2005. We had ramped up our inventory of finished goods during the fiscal year ended June 30, 2004, because we were anticipating more sales in China, which did not occur, and we expected during that fiscal year to receive FDA approval to sell the CTLM(R) system in the U.S. market.

We have revised our MD&A to disclose that some CTLM(R) systems in finished goods will be used as demonstrators or for clinical collaboration and at the conclusion of the demonstration or clinical collaboration period may be sold at reduced prices. Raw materials used for research and development or other purposes are expensed and not included in inventory. We have revised our disclosure in conformance with SAB Topic 5-BB to include our end of quarter methods and procedures to write down our carrying costs of inventory based on its

<PAGE>

Securities and Exchange Commission Division of Corporate Finance June 7, 2005 Page 3

utility, physical obsolescence, changes in price levels or other causes. We have expanded our disclosure to explain why we believe our inventories are recoverable.

3. We have revised our MD&A, Item 7 to include a section on Critical Accounting Policies pertaining to inventory.

4. We have revised our disclosure to include "completed units under testing" as a component of work in process and added finished goods as a new component. All units, whether completed and undergoing final testing in our factory or finished goods, are units available and held for sale. The CTLM(R) is a production unit manufactured by our Company and is currently being sold in the International market. Any new designs, construction and testing of pre-production prototypes and models would be expensed as Research and Development in accordance with FAS 2, paragraph 9.

Financial Statements - Page 35 ------------------------------

5. We have revised our Form 10-K to include the selected quarterly financial data required by Item 302 of Regulation S-K.

Statement of Cash Flows - Page F-14 -----------------------------------

6. We have corrected the typographical errors in the placement of brackets in the working capital liability line items in our Statement of Cash Flows. These revisions will present our cash flows in accordance with FAS 95.

7. We have revised our cash flow statement to reflect the "Inventory valuation adjustment" as a reconciling item to net loss and the inventory change has now been reflected as a cash outflow.

8. We have corrected the typographical errors of duplicating the entry of $492,701 in both the cash and non-cash sections regarding proceeds from exercise of stock options by deleting the non-cash entry. We have revised our cash flow statement to comply with the requirements of FAS 95. Further details are provided in a supplemental response.

Note 2(b) Revenue Recognition - Page F-17 -----------------------------------------

9. A supplemental narrative is provided regarding our policies and procedures for sales and matters pertaining to revenue recognition.

10. An additional supplemental response is provided regarding our policies, terms and conditions with our distributors. We have expanded the disclosure of our revenue recognition policy in note 2(b) to clarify our conformance to the guidance provided in SAB 104.

<PAGE>

Securities and Exchange Commission Division of Corporate Finance June 7, 2005 Page 4

Note 2(e) Prototype Equipment - Page F-18 -----------------------------------------

11. Our initial pre-production models were manufactured one at a time by our engineering group and, upon completion, were deemed prototypes because they were original models and were to set the standard for future production. They were not expensed as a period cost to research and development because they were full-scale fully functional units to be used as demo units to gather indications of interest from the medical community. From 1994 to 1998, it was management's opinion that prototypes could be sold after the demonstration period. Richard J. Grable, our late co-founder, invented the first CT laser breast scanner in 1989. There already existed a basis in science for Computed Tomography (CT) dating back to 1972 and published scientific literature supported the use of lasers in medical optical imaging. These combined facts were pervasive evidence that technological feasibility was established prior to our manufacture of the units thus supporting the capitalization of the pre-production models as prototypes. It was also management's opinion that the pre-production models could not be deemed inventory because they were made one at a time, the design was not finalized and we had not obtained the initial approvals from UL, ISO or CE.

A chronology was presented in Note 2 (e) "Prototype Equipment" disclosing that certain items in the prototypes were re-classed to research and development expense and computer and lab equipment. During the fiscal year ended June 30, 1998, a decision by management was made to re-class various pre-production units available for sale to inventory and the remaining costs were expensed to research and development. Any costs associated with new design or development were and currently are being expensed to research and development in accordance with FAS 2. We have revised note 2 (e) "Prototype equipment" in our amended 10-K as it no longer has relevance in the presentation of our financial statements.

Note 2(m) Intangible Assets - Page F-21 ---------------------------------------

12. The useful lives of our UL and CE approvals, which were obtained through the use of outside consulting firms, are infinite. We determined that the costs associated with obtaining these initial approvals for our CTLM(R) Model 1020 represent a core expenditure having an infinite life. The costs associated with maintenance fees, upgrades or inspection fees are expensed as period costs. We have expanded our disclosure in note 7 "Other Assets", to include relevant information as provided in the guidance of FAS 142. Further disclosure regarding these approvals has been included in our supplemental response.

13. We have provided our rationale as to why our UL and CE approvals are intangible assets in a supplemental response.

<PAGE>

Securities and Exchange Commission Division of Corporate Finance June 7, 2005 Page 5

14. The core costs of obtaining the initial UL and CE approvals have an infinite life, and intangible assets having an infinite life are not amortized at the point of acquisition or subsequent to point of acquisition in accordance with the guidance of FAS 142. We have faithfully followed the guidance provided in a paradigm, Figure 23-1: Summary of Accounting for Intangible Assets by FAS-142, in which questions are asked relative to infinite life, asset impairment and whether assumption of infinite life is still valid. For the fiscal year ended June 30, 2004, we determined that our assumption of infinite life was still valid. Thus, the intangible asset was not subject to amortization. This intangible asset is tested for impairment annually, and should it be deemed impaired, the scope of its impairment will be determined and the appropriate charge to expense will be recorded.

Note 4. Going Concern - Page F-24 ---------------------------------

15. We have revised our Going Concern disclosure to further explain that, while we have commenced our planned principal operations, we are a development stage enterprise because we have not yet produced significant revenues. FAS 7 does not provide guidance on what constitutes "significant" revenue; therefore, we must use our judgment in determining whether our Company is a development stage enterprise. In accordance with the guidance provided in FAS 7, par. 9, we deem ourselves a development stage enterprise because: 1. Our revenues are very small relative to our cash requirements. 2. We rely on our Fourth Private Equity Credit Agreement for raising capital. 3. We are developing markets through the appointment of international distributors. 4. We are training distributors in the sales and service of our product.

We would be able to exit FAS 7 reporting upon having sufficient revenues for two successive quarters where we would not have to utilize our Fourth Private Equity Credit Agreement or other financing for capital to cover our quarterly operating expenses.

Note 9. Other Current Liabilities - Page F-27 ---------------------------------------------

16. We have explained the nature and origin of the accrued liability and the accounting theory used in recording the accrued compensation as a liability for stock options. We have added a footnote to note 9 "Other Current Liabilities" clarifying our disclosure. We are adopting FASB's Statement of Financial Accounting Standards No. 123R commencing with our fiscal year beginning July 1, 2005.

Note 14. Income Taxes - Page F-31 ---------------------------------

17. We have revised note 14 to include additional disclosure to state that there is no limitation as to the utilization of the net operating losses in future years

<PAGE>

Securities and Exchange Commission Division of Corporate Finance June 7, 2005 Page 6

resulting from issuance of additional common stock during the fiscal year ended June 30, 2004. We have provided further explanation in a supplemental response.

Item 9A. Controls and Procedures - Page 36 ------------------------------------------

18. We have revised our disclosure of Controls and Procedures in Item 9A in accordance with Item 307 of Regulation S-K and have amended our filing to disclose management's conclusion regarding the effectiveness of disclosure controls and procedures as of the end of the period covered by the annual report.

Show Raw Text
<DOCUMENT>
<TYPE>CORRESP
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>

                          [ LETTERHEAD OF REGISTRANT ]

                                  June 7, 2005

VIA EDGAR AND UPS RED
---------------------

Gary Todd, Reviewing Accountant
Securities and Exchange Commission
Division of Corporate Finance
Mail Stop 03-06
450 Fifth Street, N.W.
Washington, D.C. 20549-0306

                  Re:      Imaging Diagnostic Systems, Inc.
                           Form 10-K for the Fiscal Year Ended June 30, 2004
                           Filed September 17, 2004
                           Quarterly Report on Form 10-Q for the period ended
                           December 31, 2004
                           File No.:  000-26028

Dear Mr. Todd:

         In connection with the review of the above-captioned Form 10-K and Form
10-Q for Imaging Diagnostic Systems, Inc. (the "Company"), we are responding to
your comments set forth in your letter dated April 7, 2005, to Allan L.
Schwartz, Executive Vice President and Chief Financial Officer of the Company,
which was received in our office by Fax on April 8, 2005. We have enclosed the
following documents to assist you in expediting our review:

     1.   This cover letter
     2.   Original letter containing supplemental information - Confidential
          Version
     3.   Copy of letter containing supplemental information - Redacted Version
     4.   Copy of FOIA Confidential Treatment Request Letter
     5.   Marked copy of Amendment No. 1 to our Form 10-K showing changes from
          their filing date (without exhibits)
     6.   Marked copy of Amendment No. 1 to our Form 10-Q showing changes from
          their filing date (without exhibits)

This cover letter, the redacted supplemental information letter and our amended
Form 10-K and Form 10-Q have been filed with the Commission via EDGAR earlier
today.

Form 10-K for the Fiscal Year Ended June 30, 2004

Item 7. Management's Discussion and Analysis of Financial Condition and Results
        -----------------------------------------------------------------------
        of Operations - Page 27
        -----------------------

Results of Operations - Page 27
-------------------------------

<PAGE>

Securities and Exchange Commission
Division of Corporate Finance
June 7, 2005
Page 2

Balance Sheet Data - Page 28
----------------------------

     1.   We have revised our MD&A to expand our discussion and quantify
          significant factors where the result in each line item has been
          impacted by more than one factor.

     2.   We have revised our MD&A to more fully describe our inventory, which
          consists of raw materials, work in process and finished goods. We have
          also revised Note 5, "Inventories," to conform to these three
          categories. Our raw materials consist of parts, most of which are not
          readily available because of long lead times from manufacturers or
          distributors, and custom fabricated parts and assemblies, which always
          have a long lead-time. Examples of some of our costly parts and
          assemblies which have long-lead times are laser diodes, custom
          aluminum frames, precision machined parts, custom fiberglass
          enclosures, and custom printed circuit boards.

          As a medical device manufacturer, we must adhere to very high
          standards of control and quality assurance. Our sole product, the
          CTLM(R), is a CT scanner, which, when completed, must undergo
          extensive in-house inspection and testing. We have revised our
          disclosure to include "completed units under testing" as a component
          of work in process. Once inspection and testing of a CTLM(R) has been
          completed, it will be deemed finished goods.

          All of the current inventory consisting of raw materials and work in
          process will, during the normal course of manufacturing the CTLM(R),
          result in finished goods available for sale. We are in the process of
          international globalization and have appointed distributors to sell
          our product and have placed systems for demonstration and clinical
          collaboration to create awareness of our product. All of these systems
          will be available for sale and the carrying costs of these systems
          have been and will continue to be written down to the lower of cost or
          market on a quarterly basis. We expect to recover our investment
          because the CTLM(R) is new technology and is currently the only CT
          scanner dedicated to breast imaging capable of producing three
          dimensional images using a laser beam instead of ionizing X-ray. Our
          international marketing program is underway and we have reported the
          sale of three CTLM(R) systems in the quarter ending March 31, 2005. We
          had ramped up our inventory of finished goods during the fiscal year
          ended June 30, 2004, because we were anticipating more sales in China,
          which did not occur, and we expected during that fiscal year to
          receive FDA approval to sell the CTLM(R) system in the U.S. market.

          We have revised our MD&A to disclose that some CTLM(R) systems in
          finished goods will be used as demonstrators or for clinical
          collaboration and at the conclusion of the demonstration or clinical
          collaboration period may be sold at reduced prices. Raw materials used
          for research and development or other purposes are expensed and not
          included in inventory. We have revised our disclosure in conformance
          with SAB Topic 5-BB to include our end of quarter methods and
          procedures to write down our carrying costs of inventory based on its

<PAGE>

Securities and Exchange Commission
Division of Corporate Finance
June 7, 2005
Page 3

          utility, physical obsolescence, changes in price levels or other
          causes. We have expanded our disclosure to explain why we believe our
          inventories are recoverable.

     3.   We have revised our MD&A, Item 7 to include a section on Critical
          Accounting Policies pertaining to inventory.

     4.   We have revised our disclosure to include "completed units under
          testing" as a component of work in process and added finished goods as
          a new component. All units, whether completed and undergoing final
          testing in our factory or finished goods, are units available and held
          for sale. The CTLM(R) is a production unit manufactured by our Company
          and is currently being sold in the International market. Any new
          designs, construction and testing of pre-production prototypes and
          models would be expensed as Research and Development in accordance
          with FAS 2, paragraph 9.

Financial Statements - Page 35
------------------------------

     5.   We have revised our Form 10-K to include the selected quarterly
          financial data required by Item 302 of Regulation S-K.

Statement of Cash Flows - Page F-14
-----------------------------------

     6.   We have corrected the typographical errors in the placement of
          brackets in the working capital liability line items in our Statement
          of Cash Flows. These revisions will present our cash flows in
          accordance with FAS 95.

     7.   We have revised our cash flow statement to reflect the "Inventory
          valuation adjustment" as a reconciling item to net loss and the
          inventory change has now been reflected as a cash outflow.

     8.   We have corrected the typographical errors of duplicating the entry of
          $492,701 in both the cash and non-cash sections regarding proceeds
          from exercise of stock options by deleting the non-cash entry. We have
          revised our cash flow statement to comply with the requirements of FAS
          95. Further details are provided in a supplemental response.

Note 2(b) Revenue Recognition - Page F-17
-----------------------------------------

     9.   A supplemental narrative is provided regarding our policies and
          procedures for sales and matters pertaining to revenue recognition.

     10.  An additional supplemental response is provided regarding our
          policies, terms and conditions with our distributors. We have expanded
          the disclosure of our revenue recognition policy in note 2(b) to
          clarify our conformance to the guidance provided in SAB 104.

<PAGE>

Securities and Exchange Commission
Division of Corporate Finance
June 7, 2005
Page 4

Note 2(e) Prototype Equipment - Page F-18
-----------------------------------------

     11.  Our initial pre-production models were manufactured one at a time by
          our engineering group and, upon completion, were deemed prototypes
          because they were original models and were to set the standard for
          future production. They were not expensed as a period cost to research
          and development because they were full-scale fully functional units to
          be used as demo units to gather indications of interest from the
          medical community. From 1994 to 1998, it was management's opinion that
          prototypes could be sold after the demonstration period. Richard J.
          Grable, our late co-founder, invented the first CT laser breast
          scanner in 1989. There already existed a basis in science for Computed
          Tomography (CT) dating back to 1972 and published scientific
          literature supported the use of lasers in medical optical imaging.
          These combined facts were pervasive evidence that technological
          feasibility was established prior to our manufacture of the units thus
          supporting the capitalization of the pre-production models as
          prototypes. It was also management's opinion that the pre-production
          models could not be deemed inventory because they were made one at a
          time, the design was not finalized and we had not obtained the initial
          approvals from UL, ISO or CE.

          A chronology was presented in Note 2 (e) "Prototype Equipment"
          disclosing that certain items in the prototypes were re-classed to
          research and development expense and computer and lab equipment.
          During the fiscal year ended June 30, 1998, a decision by management
          was made to re-class various pre-production units available for sale
          to inventory and the remaining costs were expensed to research and
          development. Any costs associated with new design or development were
          and currently are being expensed to research and development in
          accordance with FAS 2. We have revised note 2 (e) "Prototype
          equipment" in our amended 10-K as it no longer has relevance in the
          presentation of our financial statements.

Note 2(m) Intangible Assets - Page F-21
---------------------------------------

     12.  The useful lives of our UL and CE approvals, which were obtained
          through the use of outside consulting firms, are infinite. We
          determined that the costs associated with obtaining these initial
          approvals for our CTLM(R) Model 1020 represent a core expenditure
          having an infinite life. The costs associated with maintenance fees,
          upgrades or inspection fees are expensed as period costs. We have
          expanded our disclosure in note 7 "Other Assets", to include relevant
          information as provided in the guidance of FAS 142. Further disclosure
          regarding these approvals has been included in our supplemental
          response.

     13.  We have provided our rationale as to why our UL and CE approvals are
          intangible assets in a supplemental response.

<PAGE>

Securities and Exchange Commission
Division of Corporate Finance
June 7, 2005
Page 5

     14.  The core costs of obtaining the initial UL and CE approvals have an
          infinite life, and intangible assets having an infinite life are not
          amortized at the point of acquisition or subsequent to point of
          acquisition in accordance with the guidance of FAS 142. We have
          faithfully followed the guidance provided in a paradigm, Figure 23-1:
          Summary of Accounting for Intangible Assets by FAS-142, in which
          questions are asked relative to infinite life, asset impairment and
          whether assumption of infinite life is still valid. For the fiscal
          year ended June 30, 2004, we determined that our assumption of
          infinite life was still valid. Thus, the intangible asset was not
          subject to amortization. This intangible asset is tested for
          impairment annually, and should it be deemed impaired, the scope of
          its impairment will be determined and the appropriate charge to
          expense will be recorded.

Note 4. Going Concern - Page F-24
---------------------------------

    15.   We have revised our Going Concern disclosure to further explain that,
          while we have commenced our planned principal operations, we are a
          development stage enterprise because we have not yet produced
          significant revenues. FAS 7 does not provide guidance on what
          constitutes "significant" revenue; therefore, we must use our judgment
          in determining whether our Company is a development stage enterprise.
          In accordance with the guidance provided in FAS 7, par. 9, we deem
          ourselves a development stage enterprise because:
          1.   Our revenues are very small relative to our cash requirements.
          2.   We rely on our Fourth Private Equity Credit Agreement for raising
               capital.
          3.   We are developing markets through the appointment of
               international distributors.
          4.   We are training distributors in the sales and service of our
               product.

          We would be able to exit FAS 7 reporting upon having sufficient
          revenues for two successive quarters where we would not have to
          utilize our Fourth Private Equity Credit Agreement or other financing
          for capital to cover our quarterly operating expenses.

Note 9. Other Current Liabilities - Page F-27
---------------------------------------------

     16.  We have explained the nature and origin of the accrued liability and
          the accounting theory used in recording the accrued compensation as a
          liability for stock options. We have added a footnote to note 9 "Other
          Current Liabilities" clarifying our disclosure. We are adopting FASB's
          Statement of Financial Accounting Standards No. 123R commencing with
          our fiscal year beginning July 1, 2005.

Note 14. Income Taxes - Page F-31
---------------------------------

     17.  We have revised note 14 to include additional disclosure to state that
          there is no limitation as to the utilization of the net operating
          losses in future years

<PAGE>

Securities and Exchange Commission
Division of Corporate Finance
June 7, 2005
Page 6

          resulting from issuance of additional common stock during the fiscal
          year ended June 30, 2004. We have provided further explanation in a
          supplemental response.

Item 9A. Controls and Procedures - Page 36
------------------------------------------

     18.  We have revised our disclosure of Controls and Procedures in Item 9A
          in accordance with Item 307 of Regulation S-K and have amended our
          filing to disclose management's conclusion regarding the effectiveness
          of disclosure controls and procedures as of the end of the period
          covered by the annual report.

     1