FDA 510(k) Application Details - K150873

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K150873
Device Name Accelerator, Linear, Medical
Applicant ACCURAY INCORPORATED
1310 CHESAPEAKE TERRACE
SUNNYVALE, CA 94089 US
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Contact Shweta Kaushik
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 04/01/2015
Decision Date 07/01/2015
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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