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510(k) K122951

XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110 by Icad, Inc. — Product Code JAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2013
Date Received
September 25, 2012
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

Other clearances by Icad, Inc.

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  • K182373 — PowerLook Tomo Detection V2 Software (December 6, 2018)
  • K180125 — PowerLook Density Assessment Software (April 5, 2018)
  • K153570 — Axxent Electronic Brachytherapy System Model 110 XP 1200 (February 25, 2016)
  • K141343 — AXXENT CERVICAL APPLICATOR (September 5, 2014)
  • K123442 — XOFT AXXENT CERVICAL APPLICATORS (February 27, 2013)
  • K121517 — VERSAVUE ENTERPRISE SUITE (July 20, 2012)

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  • K173425 — SRT-100+ (March 23, 2018)
  • K172080 — Photoelectric Therapy System (September 29, 2017)
  • K162568 — INTRABEAM 600 (December 15, 2016)
  • K153570 — Axxent Electronic Brachytherapy System Model 110 XP 1200 (February 25, 2016)