510(k) K173631 ยท OWB Interventional Fluoroscopic X-Ray System
Intelli-C
| Applicant | Nrt X-Ray A/S, Hasselager, DK |
| Decision | Substantially Equivalent, Jul 11, 2018 |
| Received | Nov 24, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173631
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 7, 2024 | NRT X-RAY A/S Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system Open, Classified |
OWB | None listed |
| May 31, 2023 | NRT X-RAY A/S Intelli-C, Right side suspended Tabletop, REF: 03400000 Open, Classified |
OWB | None listed |
| May 31, 2023 | NRT X-RAY A/S Intelli-C, Left side suspended Tabletop, REF: 03400010 Open, Classified |
OWB | None listed |
| Jan 21, 2022 | NRT X-RAY A/S 1. Footrest ( use exclusively in combination with Intelli-C devices)
2. Shoulder support ( use exclusively in combination with Intelli-C devices) Open, Classified |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.