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FDA 510(k) Application Details - K083734
Device Classification Name
System, Therapeutic, X-Ray
More FDA Info for this Device
510(K) Number
K083734
Device Name
System, Therapeutic, X-Ray
Applicant
XOFT, INC.
345 POTRERO AVE.
SUNNYVALE, CA 94085 US
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Contact
STEVE LIN
Other 510(k) Applications for this Contact
Regulation Number
892.5900
More FDA Info for this Regulation Number
Classification Product Code
JAD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/16/2008
Decision Date
02/11/2009
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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