510(k) K033418 ยท JAK System, X-Ray, Tomography, Computed
TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS
| Applicant | Toshiba America Medical Systems, In.C, Tustin CA, US |
| Decision | Substantially Equivalent, Nov 10, 2003 |
| Received | Oct 27, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033418
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 19, 2010 | Toshiba American Medical Systems Inc Aquilion 32 CT System; Model number TSX-101 A/E
The product is an x-ray device that uses digital geometry to generate a three-dimensional image of the inside of an object from a large series of two- Terminated |
JAK | None listed |
| Mar 19, 2010 | Toshiba American Medical Systems Inc Aquilion 64 CT System; Model number TSX-101 A/D
The product is an x-ray device that uses digital geometry to generate a three-dimensional image of the inside of an object from a large series of two- Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.