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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 K982795
Device Name PHILIPS BUCKY VISION
Applicant
PHILIPS MEDICAL SYSTEMS, INC.
710 BRIDGEPORT AVE.
SHELTON,  CT  06484 -4708
Applicant Contact PETER ALTMAN
Correspondent
PHILIPS MEDICAL SYSTEMS, INC.
710 BRIDGEPORT AVE.
SHELTON,  CT  06484 -4708
Correspondent Contact PETER ALTMAN
Regulation Number892.1680
Classification Product Code
MQB  
Subsequent Product Code
KPR  
Date Received08/10/1998
Decision Date 11/24/1998
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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