510(k) K170177 ยท JAK System, X-Ray, Tomography, Computed
Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1
| Applicant | Toshibamedical Systems Corporation, Otawara-Shi, JP |
| Decision | Substantially Equivalent, Jun 30, 2017 |
| Received | Jan 19, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170177
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 10, 2020 | Canon Medical System, USA, INC. Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1 Open, Classified |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.