510(k) K121553 ยท JAK System, X-Ray, Tomography, Computed
AQUILION RXL
| Applicant | Toshibamedical Systems Corporation, Tustin CA, US |
| Decision | Substantially Equivalent, Jul 26, 2012 |
| Received | May 25, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121553
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 3, 2014 | Toshiba American Medical Systems Inc TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquilion RXL Computed Tomography X-Ray System; TSX-301A Aquilion One Computed Tomography X-Ray System; TSX-301B Aquilion Premium Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.