510(k) K241300 · LLZ System, Image Processing, Radiological
ViewPoint 6
| Applicant | Ge Healthcare GmbH, München, DE |
| Decision | Substantially Equivalent, Jul 2, 2024 |
| Received | May 9, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241300
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2025 | GE Healthcare GmbH GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system Open, Classified |
LLZ | None listed |
| Sep 13, 2024 | GE Healthcare GmbH ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; system, imaging processing, radiological Open, Classified |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.