Xstrahl Limited

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1404-2022Class IIX80 RADiant Photoelectric Therapy SystemApril 27, 2022
Z-0389-2022Class IITreatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy systemAugust 27, 2021
Z-0174-2022Class IIConcerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic April 26, 2021