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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Thermographic, Liquid Crystal
510(k) Number K872962
Device Name BREAST-SCAN(TM)
Applicant
Thermascan, Inc.
500 Fifth Ave.
New York,  NY  10110
Applicant Contact GYAN, PH.D.
Correspondent
Thermascan, Inc.
500 Fifth Ave.
New York,  NY  10110
Correspondent Contact GYAN, PH.D.
Regulation Number884.2982
Classification Product Code
LHM  
Date Received07/29/1987
Decision Date 10/20/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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