FDA 510(k) Application Details - K961637

Device Classification Name System, Image Processing, Radiological

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510(K) Number K961637
Device Name System, Image Processing, Radiological
Applicant PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
5500 AVION PARK DR.
HIGHLAND HEIGHTS, OH 44143 US
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Contact ELAINE K KEELER, PH.D.
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 04/29/1996
Decision Date 07/03/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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