510(k) K113466 ยท JAK System, X-Ray, Tomography, Computed
AQUILION ONE
| Applicant | Toshiba Medical Systems Coporation, Japan, Tustin CA, US |
| Decision | Substantially Equivalent, Apr 10, 2012 |
| Received | Nov 22, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113466
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2015 | Toshiba American Medical Systems Inc Toshiba Aquilion CT System TSX-301A Terminated |
JAK | None listed |
| Nov 26, 2014 | Toshiba American Medical Systems Inc Cardiac Function Analysis Software
Product Data No. MPDCT0301EAD
CSCF-003A
The software is applicable to the following CT systems:
Aquilion ONE TSX-301A/2D
X-ray CT system with a 320-row 0.5 mm det 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.