510(k) K192832 ยท JAK System, X-Ray, Tomography, Computed
Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i
| Applicant | Canon Medical Systems Corporation, Otawara-Shi, JP |
| Decision | Substantially Equivalent, Feb 21, 2020 |
| Received | Oct 2, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192832
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 9, 2020 | Canon Medical System, USA, INC. Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display cross-sectional volumes of the whole body, including the head. Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.