510(k) K122842 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
RADREX-I, SW V4.00 MODEL DRAD-3000E
| Applicant | Toshiba America Medical Systems, In.C, Tustin CA, US |
| Decision | Substantially Equivalent, Oct 9, 2012 |
| Received | Sep 17, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K122842
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2018 | Canon Medical System, USA, INC. Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005
Product Usage:
The RADREX-I is a general purpose x-ray system that employs Solid State Imager(s), SSXI, which Terminated |
MQB | None listed |
| Apr 18, 2018 | Canon Medical System, USA, INC. DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD) Terminated |
MQB | None listed |
| Mar 23, 2017 | Toshiba American Medical Systems Toshiba Medical Radrex - i Digital Radiography X-ray system
Radrex-i is intended for use in conjunction with the ceiling suspended tube support, high voltage generator, and bucky stand or bucky tab Terminated |
MQB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.