510(k) K200360 ยท OWB Interventional Fluoroscopic X-Ray System
TrackX
| Applicant | Track X Technology, LLC, Chapel Hill NC, US |
| Decision | Substantially Equivalent, Mar 5, 2020 |
| Received | Feb 13, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K200360
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2024 | Trackx Technology Inc Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking Open, Classified |
OWB | None listed |
| Feb 9, 2023 | Trackx Technology Inc TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base Modular Instrument Tracker, 6.5L, Model #605-3TX, Sterile. Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.