510(k) K173664 ยท OWB Interventional Fluoroscopic X-Ray System
Medtronic O-arm O2 Imaging System
| Applicant | Medtronic, Inc., Littleton MA, US |
| Decision | Substantially Equivalent, Dec 29, 2017 |
| Received | Nov 29, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K173664
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 31, 2019 | Medtronic Navigation, Inc.-Littleton O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000 Terminated |
OWB | None listed |
| Sep 17, 2018 | Medtronic Navigation, Inc.-Littleton Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system:
OARM BI70002000 SYS IMAGING 02
Model: BI70002000
OARM BI70002000R SYS IMAGING 02 REFURB
Model: BI70002000R Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.