510(k) clearance
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/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90)
- 510(k) number
- K254027
- Applicant
- Sonoscape Medical Corp.
- Decision date
- Aug 24, 2026
- Date received
- Dec 16, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- IYN
- Device type
- System, Imaging, Pulsed Doppler, Ultrasonic
- Device class
- Class II
- Regulation
- 21 CFR 892.1550
- Advisory committee
- Radiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Shenzhen, CN