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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mammographic
510(k) Number K010792
Device Name MAMMOGRAPH
Applicant
Digitec Medical Service Corp.
465 Maltbie St.
Suite 407
Lawrenceville,  GA  30045
Applicant Contact JAMES J MCGINTY
Correspondent
Digitec Medical Service Corp.
465 Maltbie St.
Suite 407
Lawrenceville,  GA  30045
Correspondent Contact JAMES J MCGINTY
Regulation Number892.1710
Classification Product Code
IZH  
Date Received03/16/2001
Decision Date 04/03/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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