510(k) K072606 ยท JAK System, X-Ray, Tomography, Computed
AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM
| Applicant | Toshiba America Medical Systems, In.C, Tustin CA, US |
| Decision | Substantially Equivalent, Oct 2, 2007 |
| Received | Sep 17, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072606
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 27, 2012 | Toshiba American Medical Systems Inc TSX-301A/2 Aquilion One CT System.
The TSX-30IAl2 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and periphe Terminated |
JAK | None listed |
| Aug 28, 2012 | Toshiba American Medical Systems Inc Whole Body X--ray Scanner
This device is indicated as a whole body volume CT system. The system produces volumes of up to 320 axial slices in a single rotation. Terminated |
JAK | None listed |
| Sep 13, 2011 | Toshiba American Medical Systems Inc TSX-301A: AQUILION One; System, X-Ray, Tomography, Computed
X-Ray Tomography Terminated |
JAK | None listed |
| Sep 1, 2010 | Toshiba American Medical Systems Inc Toshiba Aquilion ONE CT SystemTSX-301 A/2D Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.