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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Scintillation (Gamma)
510(k) Number K871175
Device Name JUMBO DIGITAL GAMMACAMERA, GCA-901A
Applicant
Toshiba Medical Systems
2441 Michelle
P.O. Box 2068
Tustin,  CA  92680
Applicant Contact IKUSE
Correspondent
Toshiba Medical Systems
2441 Michelle
P.O. Box 2068
Tustin,  CA  92680
Correspondent Contact IKUSE
Regulation Number892.1100
Classification Product Code
IYX  
Date Received03/24/1987
Decision Date 03/31/1987
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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