510(k) K241665 ยท KPS System, Tomography, Computed, Emission
Omni Legend
| Applicant | Ge Medical Systems Israel, Functional Imaging, Tirat Hacarmel, IL |
| Decision | Substantially Equivalent, Aug 8, 2024 |
| Received | Jun 10, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241665
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2026 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING GE Healthcare Omni Legend, sold under the following names:
OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Ga Completed |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.