FDA 510(k) Application Details - K152488

Device Classification Name System,Planning,Radiation Therapy Treatment

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510(K) Number K152488
Device Name System,Planning,Radiation Therapy Treatment
Applicant ACCURAY INCORPORATED
1209 DEMING WAY
MADISON, WI 53717 US
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Contact ERIN DALY
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Regulation Number 892.5050

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Classification Product Code MUJ
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Date Received 08/31/2015
Decision Date 09/28/2015
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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