3 results
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27ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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X80 RADiant Photoelectric Therapy System
FDA Enforcement
Class II
·Ongoing·Xstrahl Limited·July 27, 2022
Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic Brachytherapy - 100kV Superficial X-Ray Therapy System; (2) Xstrahl 150 Electronic Brachytherapy - 150kV Superficial X-Ray Therapy System; (3) Xstrahl 200 - 225kV Superficial / Orthovoltage X-Ray Therapy System; (4) Xstrahl 300 - 300kV Orthovoltage X-Ray Therapy System; (5) Xstrahl X 80 Photoelectric Therapy System.
FDA Enforcement
Class II
·Terminated·Xstrahl Limited·November 3, 2021
Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
FDA Enforcement
Class II
·Terminated·Xstrahl Limited·December 22, 2021