510(k) K183291 ยท JAK System, X-Ray, Tomography, Computed
Supria True64 Whole-Body X-Ray CT System
| Applicant | Hitachi Healthcare Americas, Twinsburg OH, US |
| Decision | Substantially Equivalent, Feb 1, 2019 |
| Received | Nov 26, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183291
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 12, 2022 | FUJIFILM Healthcare Americas Corporation Surpria: Software Version V3.11, V3.22 Open, Classified |
JAK | None listed |
| Jul 12, 2022 | FUJIFILM Healthcare Americas Corporation Surpria 64: Software Version V3.11, V3.22 Open, Classified |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.