510(k) K181834 ยท OWB Interventional Fluoroscopic X-Ray System
Ultimax-i, DREX-UI80 (V1.60)
| Applicant | Canon Medical Systems Corporation, Otawara-Shi, JP |
| Decision | Substantially Equivalent, Jul 19, 2018 |
| Received | Jul 10, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K181834
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 8, 2020 | Canon Medical System, USA, INC. System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147 Open, Classified |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.