510(k) K962613 ยท JAD System, Therapeutic, X-Ray
DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM
| Applicant | Gulmay Medical , Ltd., Shepperton, Middlesex, GB |
| Decision | Substantially Equivalent, Sep 27, 1996 |
| Received | Jul 3, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962613
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 27, 2021 | Xstrahl Limited Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system Terminated |
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.