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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, Stationary
510(k) Number K880352
Device Name MTX GENERATOR
Applicant
Philips Medical Systems (Cleveland), Inc.
5500 Avion Park Dr.
Highland Heights,  OH  44143
Applicant Contact WILLIAM J GERBER
Correspondent
Philips Medical Systems (Cleveland), Inc.
5500 Avion Park Dr.
Highland Heights,  OH  44143
Correspondent Contact WILLIAM J GERBER
Regulation Number892.1680
Classification Product Code
KPR  
Date Received01/26/1988
Decision Date 07/14/1988
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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