510(k) K254027 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/F
| Applicant | Sonoscape Medical Corp., Shenzhen, CN |
| Decision | Substantially Equivalent, Aug 24, 2026 |
| Received | Dec 16, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254027
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.