FDA 510(k) Application Details - K123230

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K123230
Device Name Accelerator, Linear, Medical
Applicant IMPAC MEDICAL SYSTEMS, INC.
100 MATHILDA PLACE, 5TH FLOOR
SUNNYVALE, CA 94086 US
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Contact KATHRYN STINSON
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 10/15/2012
Decision Date 12/12/2012
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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