510(k) K192254 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
InnoSight Diagnostic Ultrasound System
| Applicant | Qisda Corporation, Taoyuan, TW |
| Decision | Substantially Equivalent, Sep 18, 2019 |
| Received | Aug 20, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192254
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.