510(k) K213829 ยท JAK System, X-Ray, Tomography, Computed
SCENARIA View
| Applicant | Fujifilm Healthcare Corporation, Kashiwa-Shi, JP |
| Decision | Substantially Equivalent, May 23, 2022 |
| Received | Dec 8, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213829
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 12, 2022 | FUJIFILM Healthcare Americas Corporation SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C Open, Classified |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.