| 2022-04-27 |
Class II
|
Ongoing |
Z-1404-2022 |
X80 RADiant Photoelectric Therapy System |
— |
There is a potential compatibility issue with the systems and replacement treatment applicators. |
| 2021-08-27 |
Class II
|
Terminated |
Z-0389-2022 |
Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system |
— |
Base plate may detach from the main body of the treatment applicator. |
| 2021-04-26 |
Class II
|
Terminated |
Z-0174-2022 |
Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic Brachytherapy - 100k… |
— |
If a saved treatment plan with 2 opposing beams is edited prior to approval, then Beam 2 is not updated with the changed parameters upon selecting save, resulti… |