Data / Medical devices / United Kingdom / Xstrahl Limited
Xstrahl Limited: FDA-registered device maker in WALSALL, WEST MIDLANDS Staffordshire, United Kingdom, 4 510(k) clearances
Xstrahl Limited is registered with the FDA (registration 3004561814) in WALSALL, WEST MIDLANDS Staffordshire, United Kingdom. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 4, 2024. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004561814
- Address
- Unit 2 Maybrook Road, WALSALL, WEST MIDLANDS Staffordshire, United Kingdom, WS8 7DG
- Owner or operator
- XSTRAHL LIMITED (9026784)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- May 7, 2004
- Registered through
- 2026
- Brand names listed
- RADiant Aura, X80 RADiant Photoelectric Therapy System, XBeam (v2), Xstrahl 100, Xstrahl 200, Xstrahl 300
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Planning, Radiation Therapy Treatment | MUJ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Therapeutic, X-Ray | JAD | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 4, 2024 | K240671 | XBeam (v2) | MUJ | Substantially Equivalent | Xstrahl, Ltd. | accessdata.fda.gov |
| July 13, 2023 | K230611 | X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) | JAD | Substantially Equivalent | Xstrahl, Ltd. | accessdata.fda.gov |
| September 29, 2017 | K172080 | Photoelectric Therapy System | JAD | Substantially Equivalent | Xstrahl, Ltd. | accessdata.fda.gov |
| September 27, 1996 | K962613 | DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM | JAD | Substantially Equivalent | Gulmay Medical , Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 27, 2022 | 90231 | Class II | Ongoing | X80 RADiant Photoelectric Therapy System | There is a potential compatibility issue with the systems and replacement treatment applicators. | accessdata.fda.gov |
| August 27, 2021 | 88545 | Class II | Terminated | 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. | accessdata.fda.gov |
| April 26, 2021 | 88732 | Class II | Terminated | 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 | 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. | accessdata.fda.gov |
Compare with other makers
Updated December 4, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.