DeviceSignal · 510(k) cleared
Sonoscape Medical Corp.
FDA 510(k) decision recorded 2026-08-24 · K254027 · Traditional 510(k)
Event510(k) cleared
Effective2026-08-24
DecisionSESE
On 2026-08-24 the FDA recorded a 510(k) clearance decision for Sonoscape Medical Corp., for Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90…. Clearance K254027. Product code IYN. A clearance is a regulatory decision, not an endorsement of the device.
Reported facts
- 510(k) number
- K254027
- Applicant
- Sonoscape Medical Corp.
- Device
- 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)
- Decided on
- 2026-08-24
- Received on
- 2025-12-16
- Decision
- SESE
- Clearance type
- Traditional
- Product code
- IYN
- Review days
- 251
Every field above is as fda_device_510k published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_510k
- Source record
K254027- Snapshot hash
a17b676375c92ad46cfd0c81b2c18852150764f05c544c0889e193548d652e00- Source URL
- https://download.open.fda.gov/device/510k/device-510k-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_510k_to_clearance v1- Event rule
fda_device_510k_cleared v1- Event key
5f5c99802d4c0797bb6b6d49a933be9e9ce293937c32a03cbecc833081ee3aeb- Signal type
device_clearance.granted
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)