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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number K254027
Device Name 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)
Applicant
Sonoscape Medical Corp.
Rm. 201 & 202, 12th Bldg.
Shenzhen Software Park Phase Ii, 1 Keji Middle 2nd Rd.
Shenzhen,  CN 518057
Applicant Contact Toki Wu
Correspondent
Sonoscape Medical Corp.
Rm.201&202,12th Bldg.ShenzhenSoftwarePark PhaseII
1KejiMiddle2ndRd.YuehaiSubdistrict,NanshanDistrict
Shenzhen,  CN 518057
Correspondent Contact Toki Wu
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received12/16/2025
Decision Date 08/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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