FDA 510(k) Application Details - K011694

Device Classification Name System, Image Processing, Radiological

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510(K) Number K011694
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 05/31/2001
Decision Date 08/29/2001
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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