510(k) K132222 ยท JAK System, X-Ray, Tomography, Computed
AQUILION ONE VISION, V6.0
| Applicant | Toshibamedical Systems Corporation, Tustin CA, US |
| Decision | Substantially Equivalent, Nov 7, 2013 |
| Received | Jul 17, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132222
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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-301C
X-ray CT system with a 320-row 0.5 mm detector Terminated |
JAK | None listed |
| Mar 6, 2014 | Toshiba American Medical Systems Inc TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System. Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.