510(k) K103458 ยท LLZ System, Image Processing, Radiological
VIEWPOINT 6
| Applicant | GE Healthcare, Waukesha WI, US |
| Decision | Substantially Equivalent, Mar 4, 2011 |
| Received | Nov 23, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103458
| 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 |
| Aug 27, 2013 | GE Healthcare, LLC GE Ultrasound ViewPoint 6.
Product Usage: ViewPoint is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electron Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.