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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K983140
Device Name CT BIOPSYVIEW
Applicant
Philips Medical Systems North America, Inc.
710 Bridgeport Ave.
P.O. Box 860
Shelton,  CT  06484
Applicant Contact PETER ALTMAN
Correspondent
Philips Medical Systems North America, Inc.
710 Bridgeport Ave.
P.O. Box 860
Shelton,  CT  06484
Correspondent Contact PETER ALTMAN
Regulation Number892.1750
Classification Product Code
JAK  
Date Received09/08/1998
Decision Date 11/04/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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