Sonoscape Medical Corp. is one of 1554 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 (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), Digital Color Doppler Ultrasound System (P60 Series)
25
Total
25
Cleared
0
Denied
Sonoscape Medical Corp. has 25 FDA 510(k) cleared radiology devices. Based in Shenzhen, CN.
Latest FDA clearance: May 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.
25 devices
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
Cleared
Sep 05, 2018
HD-500 Video Endoscope System
Gastroenterology & Urology
253d
Cleared
Dec 05, 2017
P20 Series Digital Color Doppler Ultrasound System
Radiology
69d
Cleared
Dec 01, 2017
P10 Series Digital Color Doppler Ultrasound System
Radiology
64d
Cleared
Sep 21, 2017
S60 Series Digital Color Doppler Ultrasound System
Radiology
73d
Cleared
Jul 12, 2017
P50 Series Digital Color Doppler Ultrasound System
Radiology
100d
Cleared
Jul 11, 2017
P60 Series Digital Color Doppler Ultrasound System
Radiology
99d
Cleared
May 19, 2017
E5 Series Digital Color Doppler Ultrasound System
Radiology
108d
Cleared
Jan 03, 2017
X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System
Radiology
28d
Cleared
Apr 04, 2016
S45 Digital Color Doppler Ultrasound System
Radiology
61d
Cleared
Apr 01, 2016
X5 Digital Color Doppler Ultrasound System
Radiology
60d
Cleared
Jan 13, 2016
S50 Digital Color Doppler Ultrasound System
Radiology
106d
Cleared
Sep 03, 2015
S12 Digital Color Doppler Ultrasound System
Radiology
10d
Cleared
Aug 28, 2015
S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System
Radiology
25d
Cleared
Aug 26, 2015
S9 Portable Digital Color Doppler Ultrasound System
Radiology
23d