510(k) K191877 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
FLUOROspeed
| Applicant | Shimadzu Corporation, Kyoto, JP |
| Decision | Substantially Equivalent, Aug 5, 2019 |
| Received | Jul 15, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191877
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2024 | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a flat detector, it can perform a range of applications including gener Open, Classified |
JAA | None listed |
| Jan 10, 2022 | Shimadzu Medical Systems MODEL: X-RAY R/F SYSTEM FLUOROspeed X1 Open, Classified |
JAA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.