510(k) K191699 ยท KPR System, X-Ray, Stationary
Discovery XR656 HD with VolumeRad
| Applicant | Ge Hualun Medical Systems Co. , Ltd., Beijing, CN |
| Decision | Substantially Equivalent, Jul 24, 2019 |
| Received | Jun 25, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191699
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 3, 2025 | GE Medical Systems, LLC Discovery XR656HD. X-Ray imaging system. Open, Classified |
KPR | None listed |
| Dec 14, 2023 | GE Hangwei Medical Systems, Co. LTD The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The Open, Classified |
KPR | None listed |
| Dec 14, 2023 | GE Hangwei Medical Systems, Co. LTD The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The Open, Classified |
KPR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.