GeneralDevices & AI clearances
FDA clears Sonoscape digital color Doppler ultrasound systems (Marvo/Fenix/Endo series)
U.S. FDA2w ago
Sonoscape Medical Corp. received FDA 510(k) clearance for its family of digital color Doppler ultrasound systems, including the Marvo, Fenix, and Endo series. The devices were classified under product code IYN and reviewed by the Radiology committee.
- The clearance covers multiple system configurations across the Marvo, Fenix, and Endo product lines.
- The FDA reviewed the device under the Radiology committee and assigned product code IYN for ultrasound imaging systems.
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