510(k) K253898 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
QT Scanner 2000 Model A
| Applicant | QT Imaging Holdings, Inc., Novato CA, US |
| Decision | Substantially Equivalent, Mar 4, 2026 |
| Received | Dec 5, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253898
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.