510(k) K251416 ยท QJU Image Acquisition And/Or Optimization Guided By Artificial Intelligence
UltraSight Guidance
| Applicant | Ultrasight , Ltd., Ness Ziona, IL |
| Decision | Substantially Equivalent, Dec 17, 2025 |
| Received | May 7, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251416
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.