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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, nuclear magnetic resonance imaging
510(k) Number K945945
Device Name GYROSCAN ACS-NT, GYROSCAN T5-NT AND GYROSCAN T10-NT
Applicant
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
710 BRIDGEPORT AVE.
SHELTON,  CT  06484
Applicant Contact PETER ALTMAN
Correspondent
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
710 BRIDGEPORT AVE.
SHELTON,  CT  06484
Correspondent Contact PETER ALTMAN
Regulation Number892.1000
Classification Product Code
LNH  
Date Received12/05/1994
Decision Date 12/22/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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