FDA 510(k) Application Details - K043146

Device Classification Name System, Image Processing, Radiological

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510(K) Number K043146
Device Name System, Image Processing, Radiological
Applicant MCKESSON MEDICAL IMAGING COMPANY
130-10711 CAMBIE ROAD
RICHMOND, B.C. V6X 3G5 CA
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Contact ROBERT MACNEIL
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 11/15/2004
Decision Date 01/04/2005
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 Y
Expedited Review



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