510(k) K150595 ยท JAK System, X-Ray, Tomography, Computed
SCENARIA Phase 3 Whole-body X-ray CT System
| Applicant | Hitachi Medical Systems America, Inc., Twinsburg OH, US |
| Decision | Substantially Equivalent, Oct 30, 2015 |
| Received | Mar 9, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150595
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2019 | Hitachi Medical Systems America Inc Hitachi Scenaria Whole-body X-ray CT System Terminated |
JAK | None listed |
| Jun 29, 2018 | Hitachi Medical Systems America Inc Hitachi Scenaria CT system
Product Usage:
The SCENARIA CT system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The images can Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.