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510(k) K141343

AXXENT CERVICAL APPLICATOR by Icad, Inc. — Product Code JAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 2014
Date Received
May 21, 2014
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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  • K180125 — PowerLook Density Assessment Software (April 5, 2018)
  • K153570 — Axxent Electronic Brachytherapy System Model 110 XP 1200 (February 25, 2016)
  • K123442 — XOFT AXXENT CERVICAL APPLICATORS (February 27, 2013)
  • K122951 — XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110 (January 17, 2013)
  • K121517 — VERSAVUE ENTERPRISE SUITE (July 20, 2012)

Other clearances for product code JAD

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  • K213942 — Esteya (January 11, 2022)
  • K190255 — Sensus Healthcare TVM Balloon Applicator (February 21, 2019)
  • K182641 — Sensus IORT System (February 21, 2019)
  • 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)