FDA 510(k) Application Details - K042146

Device Classification Name Couch, Radiation Therapy, Powered

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510(K) Number K042146
Device Name Couch, Radiation Therapy, Powered
Applicant ACCURAY INCORPORATED
1310 CHESAPEAKE TERRACE
SUNNYVALE, CA 94089 US
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Contact ANNE SCHLAGENHAFT
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Regulation Number 892.5770

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Classification Product Code JAI
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Date Received 08/09/2004
Decision Date 09/17/2004
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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