510(k) K080211 ยท JAK System, X-Ray, Tomography, Computed
MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM
| Applicant | Toshiba America Medical Systems, In.C, Tustin CA, US |
| Decision | Substantially Equivalent, Mar 14, 2008 |
| Received | Jan 29, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080211
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2015 | Toshiba American Medical Systems Inc Toshiba Aquilion CT System TSX-101A Terminated |
JAK | None listed |
| 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 |
| Sep 16, 2011 | Toshiba American Medical Systems Inc TSX-101: Aquilion 32/64; System, X-Ray, Tomography, Computed. Terminated |
JAK | None listed |
| May 19, 2011 | Toshiba American Medical Systems Inc CHVH-001A/1B Variable Helical Pitch (vHP) Software for TSX-101A: Aquilion 64; System, X-Ray, Tomography Computed Terminated |
JAK | None listed |
| Mar 19, 2010 | Toshiba American Medical Systems Inc Aquilion 32 CT System; Model number TSX-101 A/I
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-d Terminated |
JAK | None listed |
| Mar 19, 2010 | Toshiba American Medical Systems Inc Aquilion 64 CT System; Model number TSX-101 A/H
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 32 CT System; Model number TSX-101 A/K
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-d Terminated |
JAK | None listed |
| Mar 19, 2010 | Toshiba American Medical Systems Inc Aquilion 64 CT System; Model number TSX-101 A/J
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-d Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.