510(k) K152294 ยท KPR System, X-Ray, Stationary
FDR Visionary Suite
| Applicant | Shimadzu Corporation, Kyoto, JP |
| Decision | Substantially Equivalent, Jul 15, 2016 |
| Received | Aug 13, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152294
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 5, 2026 | FUJIFILM Healthcare Americas Corporation FDR Visionary Suite;
Model Number: CH-200;
Version: (1) 566-16130-23, (2) 566-16130-31, (3) Open, Classified |
KPR | None listed |
| Oct 7, 2025 | FUJIFILM Healthcare Americas Corporation FDR Visionary Suite, CH-200
Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33 Open, Classified |
KPR | None listed |
| May 24, 2024 | FUJIFILM Healthcare Americas Corporation FDR Visionary Suite - Intended to generate digital or conventional radiographic
images of the skull, spinal column, chest, abdomen, extremities, and other body parts of
human anatomies in all routine Open, Classified |
KPR | None listed |
| Jun 15, 2017 | Fujifilm Medical Systems U.S.A., Inc. FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name)
The FDR Visionary Suite is intended to generate digital or conventional radiographic images of Terminated |
KPR | None listed |
| May 23, 2017 | Shimadzu Medical Systems Usa Com SHIMADZU FDR Visionary
Catalog Number: FDR Visionary Suite
Stationary x-ray system for taking general radiographic and tomographic images of the whole body. The device is intended to be used in hos Terminated |
KPR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.