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510(k) K111299

AXXENT RADIATION SHIELD - RIGID by Xoft, an Icad Company — Product Code JAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2011
Date Received
May 9, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Therapeutic, X-Ray
Device Class
Class II
Regulation Number
892.5900
Review Panel
RA
Submission Type

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