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FDA 510(k) Application Details - K043412
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
892.2050
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Classification Product Code
LLZ
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More FDA Info for this Product Code
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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