510(k) K093891 ยท JAK System, X-Ray, Tomography, Computed
AQUILION ONE VERSION 4.6 W/DUAL ENERGY SCAN SYSTEM, MODEL TSX-301A/2
| Applicant | Toshibamedical Systems Corporation, Tustin CA, US |
| Decision | Substantially Equivalent, Nov 18, 2010 |
| Received | Dec 18, 2009 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K093891
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 10, 2020 | Canon Medical System, USA, INC. Canon Aquilion One, Model TSX-301A Open, Classified |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.