510(k) K254028 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV, e-Autra, Autra 75, Autra 85W, Autra 65, Autra 55, Autra 65i, Autra 90 Elite, Autra 85 Elite, Autra 80 Elite, Autra 75 Elite, Autra 85 CV, Autra 80W, Autra 65 Elite, Autra 55 Elite, Autra 55i, Autra 90 CV, Autra 85,
| Applicant | Sonoscape Medical Corp., Shenzhen, CN |
| Decision | Substantially Equivalent, May 15, 2026 |
| Received | Dec 16, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254028
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.