510(k) K201103 ยท LLZ System, Image Processing, Radiological
Xeleris V Processing and Review Systems
| Applicant | GE Healthcare, Tirat Hacarmel, IL |
| Decision | Substantially Equivalent, Sep 25, 2020 |
| Received | Apr 24, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201103
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.