510(k) K261132 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Healium Intelliscan LX192LC
| Applicant | Healium Intelliscan Corporation, New York, Ny NY, US |
| Decision | Substantially Equivalent, May 5, 2026 |
| Received | Apr 6, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K261132
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.