510(k) K141741 ยท JAK System, X-Ray, Tomography, Computed
AQUILION PRIME, V6.00
| Applicant | Toshibamedical Systems Corporation, Tustin CA, US |
| Decision | Substantially Equivalent, Nov 26, 2014 |
| Received | Jun 27, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141741
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2016 | Toshiba American Medical Systems Inc Aquilion Prime TSX-303A
Aquilion PRIME is a multislice helical CT system with an 40-row detector. High-speed rotation allows rapid data acquisition and shortens scan times, while the fast reconstructi Terminated |
JAK | None listed |
| Oct 9, 2015 | Toshiba American Medical Systems Inc Toshiba Aquilion CT System TSX-303A Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.