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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, X-Ray, Electrostatic
510(k) Number K931002
Device Name FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS
Applicant
Fujifilm Medical System U.S.A., Inc.
333 Ludlow St.
P.O. Box 120035
Stamford,  CT  06912
Applicant Contact ROBERT A UZENOFF
Correspondent
Fujifilm Medical System U.S.A., Inc.
333 Ludlow St.
P.O. Box 120035
Stamford,  CT  06912
Correspondent Contact ROBERT A UZENOFF
Regulation Number892.1630
Classification Product Code
IXK  
Date Received02/26/1993
Decision Date 06/08/1993
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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