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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 K910437
Device Name FUJI COMPUTED RADIOGRAPHY SYSTEM FCR 7501
Applicant
Fujifilm Medical System U.S.A., Inc.
90 Viaduct Rd.
P.O. Box 4960
Stamford,  CT  06907
Applicant Contact ROBERT A UZENOFF
Correspondent
Fujifilm Medical System U.S.A., Inc.
90 Viaduct Rd.
P.O. Box 4960
Stamford,  CT  06907
Correspondent Contact ROBERT A UZENOFF
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/31/1991
Decision Date 04/24/1991
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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