Xstrahl Limited

WALSALL, WEST MIDLANDS Staffordshire, GB

XSTRAHL LIMITED appears in FDA device records in WALSALL, WEST MIDLANDS Staffordshire, GB. FDA records list 3 510(k) clearances between 2017-09-29 and 2024-12-04, no PMA records and 2 registered establishments. As of 2026-09-10, FDA records show 3 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 3
PMA records: 0
Recall records: 3
Registered establishments: 2

510(k) clearance history

FDA records hold 3 510(k) clearances for Xstrahl Limited between 2017 and 2024. The busiest year on record is 2017, with 1. The most recent is 2024, with 1.

Clearances by year, as a table

510(k) clearance decisions for Xstrahl Limited, by decision year
Year	Clearances
2017	1
2023	1
2024	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K240671	XBeam (v2)	MUJ	Substantially Equivalent	2024-12-04
K230611	X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)	JAD	Substantially Equivalent	2023-07-13
K172080	Photoelectric Therapy System	JAD	Substantially Equivalent	2017-09-29

Registered establishments

FDA registered establishments for Xstrahl Limited, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3004561814	3004561814	XSTRAHL LIMITED	UNIT 2, WALSALL, WEST MIDLANDS Staffordshire WS8 7DG GB	2026	JAD MUJ
3006740096	3006740096	XSTRAHL, INC.	3400 Corporate Way Suite A, Duluth, GA 30096 US	2026	No device listings on this registration

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1404-2022	X80 RADiant Photoelectric Therapy System	There is a potential compatibility issue with the systems and replacement treatment applicators.	Class II	2022-04-27	Open, Classified
Z-0389-2022	Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system	Base plate may detach from the main body of the treatment applicator.	Class II	2021-08-27	Terminated
Z-0174-2022	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.	If a saved treatment plan with 2 opposing beams is edited prior to approval, then Beam 2 is not updated with the changed parameters upon selecting save, resulting in error messages during the treatment and possible mis-treatment.	Class II	2021-04-26	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain