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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K844037
Device Name DIGITAL FLUOROGRAPHIC IMAGING SYSTEM DIGIFORMER
Applicant
TOSHIBA MEDICAL SYSTEMS
2441 MICHELLE
P.O. BOX 2068
TUSTIN,  CA  92680
Applicant Contact WYATT E CANNADY
Correspondent
TOSHIBA MEDICAL SYSTEMS
2441 MICHELLE
P.O. BOX 2068
TUSTIN,  CA  92680
Correspondent Contact WYATT E CANNADY
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/16/1984
Decision Date 03/01/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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