Company ยท GB
Xstrahl, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2024. Name variants (Inc, Corp, punctuation) are merged.
3510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 27, 2022 | Xstrahl Limited X80 RADiant Photoelectric Therapy System Open, Classified |
JAD | K172080 |
| Aug 27, 2021 | Xstrahl Limited Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system Terminated |
JAD | K962613 |
| 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 | K172080 K962613 |