510(k) K190373 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
SonialVision G4
| Applicant | Shimadzu Corporation, Kyoto, JP |
| Decision | Substantially Equivalent, Mar 15, 2019 |
| Received | Feb 19, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K190373
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2024 | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examinations, including general radiography and pediatric examinations, excluding mammo Open, Classified |
JAA | None listed |
| Jan 10, 2022 | Shimadzu Medical Systems MODEL: X-RAY TV SYSSTEM SONIALVISION safire17 Open, Classified |
JAA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.