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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomographic, Nuclear
510(k) Number K851686
Device Name DIGITAL GAMMA CAMERA GCA 501S
Applicant
Toshiba Medical Systems
2441 Michelle
P.O. Box 2068
Tustin,  CA  92680
Applicant Contact WYATT CANNADY
Correspondent
Toshiba Medical Systems
2441 Michelle
P.O. Box 2068
Tustin,  CA  92680
Correspondent Contact WYATT CANNADY
Regulation Number892.1310
Classification Product Code
JWM  
Date Received04/23/1985
Decision Date 06/05/1985
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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