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510(k) K230611

X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) by Xstrahl, Ltd. — Product Code JAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2023
Date Received
March 6, 2023
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)
  • K172080 — Photoelectric Therapy System (September 29, 2017)

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)
  • 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)
  • K150037 — Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Ima (October 16, 2015)