510(k) K172080 ยท JAD System, Therapeutic, X-Ray
Photoelectric Therapy System
| Applicant | Xstrahl, Ltd., Brownhills, GB |
| Decision | Substantially Equivalent, Sep 29, 2017 |
| Received | Jul 10, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172080
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 27, 2022 | Xstrahl Limited X80 RADiant Photoelectric Therapy System Open, Classified |
JAD | None listed |
| Apr 26, 2021 | Xstrahl Limited 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 - 150 Terminated |
JAD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.