510(k) K203249 ยท LLZ System, Image Processing, Radiological
Nucleus.io
| Applicant | Nucleushealth, LLC, San Diego CA, US |
| Decision | Substantially Equivalent, Dec 4, 2020 |
| Received | Nov 4, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203249
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 14, 2023 | CHANGE HEALTHCARE CANADA COMPANY Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS. Open, Classified |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.