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510(k) K172080

Photoelectric Therapy System by Xstrahl, Ltd. — Product Code JAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2017
Date Received
July 10, 2017
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 Xstrahl, Ltd.

  • K240671 — XBeam (v2) (December 4, 2024)
  • K230611 — X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) (July 13, 2023)

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)
  • K162568 — INTRABEAM 600 (December 15, 2016)
  • K153570 — Axxent Electronic Brachytherapy System Model 110 XP 1200 (February 25, 2016)
  • K150037 — Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Ima (October 16, 2015)