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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 K922619
Device Name DIGITIZER, MODEL # 3-000A-1518
Applicant
Lorad Medical Systems, Inc.
Eagle Rd., Commerce Park
Danbury,  CT  06810
Applicant Contact EDWARD MCDERMOTT
Correspondent
Lorad Medical Systems, Inc.
Eagle Rd., Commerce Park
Danbury,  CT  06810
Correspondent Contact EDWARD MCDERMOTT
Regulation Number892.1710
Classification Product Code
IZH  
Date Received05/29/1992
Decision Date 07/01/1992
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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