FDA 510(k) Application Details - K170751

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K170751
Device Name Accelerator, Linear, Medical
Applicant ViewRay Incorporated
2 Thermo Fisher Way
Oakwood Village, OH 44146 US
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Contact Sean Delaney
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 03/13/2017
Decision Date 06/07/2017
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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