FDA applicant
Xstrahl, Ltd.
FDA records 3 decisions for Xstrahl, Ltd. (Brownhills, GB) from 2017 to 2024: 3 510(k) clearances. Most are in product codes JAD (System, Therapeutic, X-Ray) and MUJ (System, Planning, Radiation Therapy Treatment). Its devices cite 3 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Xstrahl, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
1in 2022
Class I Class II/III not classified
Planning a device like Xstrahl, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report