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510(k) K090914

AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E by Xoft, Inc. — Product Code JAD

Clearance Details

Decision
SESU ()
Decision Date
July 16, 2009
Date Received
April 1, 2009
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 Xoft, Inc.

  • K090417 — AXXENT FLEXISHIELD MINI (June 23, 2009)
  • K083734 — AXXENT SURFACE APPLICATOR, MODEL 710257 (February 11, 2009)
  • K072616 — AXXENT VAGINAL APPLICATOR (May 9, 2008)
  • K072683 — AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM (February 29, 2008)
  • K050843 — AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM (December 22, 2005)

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  • K230611 — X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) (July 13, 2023)
  • K213942 — Esteya (January 11, 2022)
  • K182641 — Sensus IORT System (February 21, 2019)
  • K190255 — Sensus Healthcare TVM Balloon Applicator (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)