510(k) K120546 ยท JAK System, X-Ray, Tomography, Computed
AQUILION PREMIUM
| Applicant | Toshiba Medical Systems Corporation, Japan, Tustin CA, US |
| Decision | Substantially Equivalent, Jun 13, 2012 |
| Received | Feb 23, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K120546
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 10, 2020 | Canon Medical System, USA, INC. Canon Aquilion Premium, Model TSX-301B Open, Classified |
JAK | None listed |
| Oct 9, 2015 | Toshiba American Medical Systems Inc Toshiba Aquilion CT System TSX-301B Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.