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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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