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510(k) K050843

AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM by Xoft, Inc. — Product Code JAD

K050843 is an FDA 510(k) premarket notification submitted by Xoft, Inc. for the device "AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM". The FDA issued a decision of SESU on December 22, 2005. The device falls under product code JAD (System, Therapeutic, X-Ray), a Class II device regulated under 21 CFR 892.5900. Xoft, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESU ()
Decision Date
December 22, 2005
Date Received
April 1, 2005
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.

  • K090914 — AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E (July 16, 2009)
  • 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)

Other clearances for product code JAD

  • K250692 — GentleBeam (GB1000) (December 3, 2025)
  • K241174 — INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spheric (January 10, 2025)
  • K230611 — X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) (July 13, 2023)
  • 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)

FDA data resources