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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Digital Image Communications, Radiological
510(k) Number K970293
Device Name FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666
Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
333 LUDLOW ST.
P.O. BOX 120035
STAMFORD,  CT  06912 -0035
Applicant Contact ROBERT A UZENOFF
Correspondent
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
333 LUDLOW ST.
P.O. BOX 120035
STAMFORD,  CT  06912 -0035
Correspondent Contact ROBERT A UZENOFF
Regulation Number892.2020
Classification Product Code
LMD  
Date Received01/24/1997
Decision Date 03/21/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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