510(k) K253639 ยท LLZ System, Image Processing, Radiological
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| Applicant | GE Healthcare, Chicago IL, US |
| Decision | Substantially Equivalent, Jan 8, 2026 |
| Received | Nov 19, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253639
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.