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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name solid state x-ray imager (flat panel/digital imager)
510(k) Number K993861
Device Name FUJI COMPUTED RADIOGRAPHY DUAL SIDE READING, BOTH SIDE READING, FCR 5501D DUAL SIDE READER
Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
419 WEST AVE.
STAMFORD,  CT  06902
Applicant Contact JOSEPH M AZARY
Correspondent
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
419 WEST AVE.
STAMFORD,  CT  06902
Correspondent Contact JOSEPH M AZARY
Regulation Number892.1680
Classification Product Code
MQB  
Date Received11/15/1999
Decision Date 02/10/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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