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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 K964124
Device Name PHILIPS COMPUTED RADIOGRAPHY
Applicant
PHILIPS MEDICAL SYSTEMS, INC.
710 BRIDGEPORT AVE.
SHELTON,  CT  06484 -4708
Applicant Contact FRANK GIANELLI
Correspondent
PHILIPS MEDICAL SYSTEMS, INC.
710 BRIDGEPORT AVE.
SHELTON,  CT  06484 -4708
Correspondent Contact FRANK GIANELLI
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/15/1996
Decision Date 12/18/1996
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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