Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United KingdomLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Xstrahl Limited with 3 510(k) clearances and 3 device recalls. The most recent is a 510(k) clearance dated Dec 4, 2024: XBeam (v2).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Dec 4, 2024 | XBeam (v2)K240671 · MUJ | 510(k) clearances |
| Jul 13, 2023 | X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)K230611 · JAD | 510(k) clearances |
| Apr 27, 2022 | X80 RADiant Photoelectric Therapy SystemClass II · There is a potential compatibility issue with the systems and replacement treatment applicators. | Device recalls |
| Sep 29, 2017 | Photoelectric Therapy SystemK172080 · JAD | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
