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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 K963990
Device Name GYROSCAN T5-NT, GYROSCAN T10-NT AND GYROSCAN ACS-NT RELEASE 5 SERIES
Applicant
Philips Medical Systems, Inc.
710 Bridgeport Ave.
P.O. Box 860
Shelton,  CT  06484
Applicant Contact PETER ALTMAN
Correspondent
Philips Medical Systems, Inc.
710 Bridgeport Ave.
P.O. Box 860
Shelton,  CT  06484
Correspondent Contact PETER ALTMAN
Regulation Number892.1000
Classification Product Code
LNH  
Date Received10/04/1996
Decision Date 05/29/1997
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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