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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assembly, Tube Housing, X-Ray, Diagnostic
510(k) Number K923141
Device Name PHILIPS PRE-FILTER OPTION
Applicant
Philips Medical Systems, Inc.
Veenpluis 4-6
P.O. Box 10000
5680 Da Best,  NL
Applicant Contact WILLIAM G MCMAHON
Correspondent
Philips Medical Systems, Inc.
Veenpluis 4-6
P.O. Box 10000
5680 Da Best,  NL
Correspondent Contact WILLIAM G MCMAHON
Regulation Number892.1760
Classification Product Code
ITY  
Date Received06/29/1992
Decision Date 01/21/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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