510(k) K203677 ยท LLZ System, Image Processing, Radiological
ViewPoint 6
| Applicant | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC, Wauwatosa WI, US |
| Decision | Substantially Equivalent, Jan 15, 2021 |
| Received | Dec 17, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K203677
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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.