510(k) K260605 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Lilium one (USM330)
| Applicant | Lilium Otsuka Co., Ltd., Kanagawa, JP |
| Decision | Substantially Equivalent, Oct 16, 2026 |
| Received | Feb 24, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260605
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.