FDA 510(k) Application Details - K171837

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K171837
Device Name Accelerator, Linear, Medical
Applicant Accuray Incorporated
1240 Deming Way
Madison, WI 53717 US
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Contact Keith Picker
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 06/20/2017
Decision Date 07/25/2017
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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