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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
Predetermined Change
Control Plan Authorized		 No
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