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510(k) K153570

Axxent Electronic Brachytherapy System Model 110 XP 1200 by Icad, Inc. — Product Code JAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 2016
Date Received
December 14, 2015
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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  • K121517 — VERSAVUE ENTERPRISE SUITE (July 20, 2012)

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