FDA 510(k) Application Details - K043412

Device Classification Name System, Image Processing, Radiological

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510(K) Number K043412
Device Name System, Image Processing, Radiological
Applicant IMPAC MEDICAL SYSTEMS, INC.
100 WEST EVELYN AVE.
MOUNTAIN VIEW, CA 94041-1464 US
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Contact THOMAS H FARIS
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 12/10/2004
Decision Date 12/20/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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