SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report
(Date of earliest event reported):
December 17, 1998
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TREX MEDICAL CORPORATION
(Exact name of Registrant as specified in its charter)
Delaware 1-11827 06-1439626
(State or other (Commission (I.R.S. Employer
jurisdiction of File Number) Identification Number)
incorporation or
organization)
37 Apple Ridge Road
Danbury, Connecticut 06810
(Address of principal executive offices) (Zip Code)
(203) 207-4500
(Registrant's telephone number
including area code)
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This Form 8-K contains forward-looking statements that involve a number of
risks and uncertainties. Important factors that could cause actual results to
differ materially from those indicated by such forward-looking statements are
set forth under the heading "Forward-looking Statements" in Exhibit 13 to the
Registrant's Annual Report on Form 10-K for the fiscal year ended September 27,
1997. These include risks and uncertainties relating to: technological change,
product development and commercialization, competition, dependency on patents
and proprietary rights, intellectual property, litigation, the Registrant's
acquisition strategy, government regulation and approvals, healthcare reform,
patient reimbursement, dependence on significant OEM relationships, potential
product liability, international operations, and the potential impact of the
year 2000 on processing date-sensitive information.
Item 5. Other Events
On December 17, 1998, the Registrant issued a press release announcing
that it has received a letter from the U.S. Food and Drug Administration (the
"FDA") notifying the Registrant that the FDA was unable, based on the data
provided, to determine substantial equivalence with analog, or "film screen,"
mammography. As a result, the FDA considers the Registrant's 510(k) application
seeking clearance to market a full-field digital mammography system to be
withdrawn.
In its letter, the FDA outlines additional data analysis that will be
required for clearance of the 510(k) application. The Registrant has been
working closely with the FDA to provide information as requested since the
Registrant submitted its 510(k) application in December 1997. During 1998, the
Registrant has continued to collect clinical data and is now in the process of
analyzing this information. The Registrant plans to meet with the FDA to discuss
its application in early 1999.
Item 7. Financial Statements, Pro Forma Financial Information and Exhibits
(a) Financial Statements of Business Acquired: not
applicable.
(b) Pro Forma Financial Information: not applicable.
(c) Exhibits: not applicable.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized, on this 17th day of December, 1998.
TREX MEDICAL CORPORATION
By:/s/ Kenneth J. Apicerno
Kenneth J. Apicerno
Treasurer
