17 results
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31ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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XSTRAHL LIMITED
FDA registration
XSTRAHL LIMITED·2 products·🇬🇧 United Kingdom
Xstrahl 300 X-Ray System - Floor
FDA UDI
XSTRAHL LIMITED·05060494200060·Xstrahl 300 X-Ray System - Floor
Xstrahl 150 X-Ray System - Ceiling
FDA UDI
XSTRAHL LIMITED·05060494200039·Xstrahl 150 X-Ray System - Ceiling
X80 / RADiant / PhotoElectric Therapy System
FDA UDI
XSTRAHL LIMITED·05060494200084·X80 / RADiant / PhotoElectric Therapy System
Xstrahl 300 X-Ray System Ceiling
FDA UDI
XSTRAHL LIMITED·05060494200077·Xstrahl 300 X-Ray System Ceiling
Xstrahl 200 X-Ray System - Ceiling
FDA UDI
XSTRAHL LIMITED·05060494200053·Xstrahl 200 X-Ray System - Ceiling
Xstrahl Photoelectric Therapy System
FDA UDI
XSTRAHL LIMITED·05060494200008·Xstrahl Photoelectric Therapy System
XBeam
FDA UDI
XSTRAHL LIMITED·05060494200091·System, Planning, Radiation Therapy Treatment
Xstrahl 200 X-Ray System - Floor
FDA UDI
XSTRAHL LIMITED·05060494200046·Xstrahl 200 X-Ray System - Floor
Xstrahl 100 X-Ray System
FDA UDI
XSTRAHL LIMITED·05060494200015·Xstrahl 100 X-Ray System
Xstrahl 150 X-Ray System Floor
FDA UDI
XSTRAHL LIMITED·05060494200022·Xstrahl 150 X-Ray System Floor
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 Recall
Terminated
·Xstrahl Limited·Product code JAD·April 26, 2021
Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
FDA Recall
Terminated
·Xstrahl Limited·Product code JAD·August 27, 2021
X80 RADiant Photoelectric Therapy System
FDA Recall
Open, Classified
·Xstrahl Limited·Product code JAD·April 27, 2022
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