FDA 510(k) Application Details - K984563

Device Classification Name System, Radiation Therapy, Radionuclide

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510(K) Number K984563
Device Name System, Radiation Therapy, Radionuclide
Applicant ACCURAY, INC.
570 DEL REY AVE.
SUNNYVALE, CA 94085 US
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Contact LUANNE TERMEER
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Regulation Number 892.5750

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Classification Product Code IWB
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Date Received 12/23/1998
Decision Date 07/14/1999
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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