Sonoscape Medical Corp. is one of 1971 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.
Sonoscape Medical Corp. - FDA 510(k) Cleared Devices
Recent clearances: 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), Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV, e-Autra, Autra 75, Autra 85W, Autra 65, Autra 55, Autra 65i, Autra 90 Elite, Autra 85 Elite, Autra 80 Elite, Autra 75 Elite, Autra 85 CV, Autra 80W, Autra 65 Elite, Autra 55 Elite, Autra 55i, Autra 90 CV, Autra 85, Autra 80, Autra 80 CV, Autra 75 Pro, Autra 75W, Autra 70 Elite, Autra 70, Autra T), Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plus/E11 Elite/X11T/X11U/X11R/X11i/X11s/E11T/E11i/E11s/XR1/XR2/ XR3/ER1/ER2/ER3/X10 Exp/X10 Elite/X10 Pro/X10 Plus/X10 Super/X10 Senior/X10/X10T/X10U/ X10R/X10i/X10s/E10/E10 Pro/E10 Plus/E10T/E10i/E10s/SU11A EXP/SU11A PRO/SU11A AD/ SU11A CU/SU11B EXP/SU11B PRO/SU11B AD/SU11B CU/SU11C EXP/SU11C PRO/SU11C AD/ SU11C CU)
26
Total
26
Cleared
0
Denied
Sonoscape Medical Corp. has 26 FDA 510(k) cleared radiology devices. Based in Shenzhen, CN.
Latest FDA clearance: Aug 2026. Active since 2015.
Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Mid-Link Consulting Co, Ltd. as regulatory consultant.
FDA 510(k) Regulatory Record - Sonoscape Medical Corp.
26 devices
Cleared
Aug 24, 2026
Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo...
Radiology
251d
Cleared
May 15, 2026
Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior,...
Radiology
150d
Cleared
Dec 05, 2025
Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11...
Radiology
119d
Cleared
Jan 17, 2025
Digital Color Doppler Ultrasound System (P60 Series)
Radiology
198d
Cleared
Mar 08, 2024
Ultrasonic Gastrovideoscope
Gastroenterology & Urology
261d
Cleared
Feb 10, 2023
S90 Exp Series Digital Color Doppler Ultrasound System
Radiology
168d
Cleared
Sep 15, 2022
P12 Elite Series Digital Color Doppler Ultrasound System
Radiology
155d
Cleared
Sep 13, 2022
P20 Elite Series Digital Color Doppler Ultrasound System
Radiology
147d
Cleared
Sep 08, 2022
HD-550 Video Endoscope System
Gastroenterology & Urology
62d
Cleared
Apr 01, 2022
HD-550 Video Endoscope System
Gastroenterology & Urology
284d
Cleared
Jul 30, 2020
S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System
Radiology
100d
Cleared
Jan 29, 2019
X5 Series Digital Color Doppler Ultrasound System
Radiology
127d