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Sonoscape Medical Corp.

FDA 510(k) & PMA Approved Devices — 22 products

Total Devices22
Categories3
Latest FDA decision2026-05-15
TypeNumberDevice NameCodeDateActions
510(k) K254028 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)IYN2026-05-15 View
510(k) K252498 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)IYN2025-12-05 View
510(k) K241949 Digital Color Doppler Ultrasound System (P60 Series)IYN2025-01-17 View
510(k) K231813 Ultrasonic GastrovideoscopeODG2024-03-08 View
510(k) K222596 S90 Exp Series Digital Color Doppler Ultrasound SystemIYN2023-02-10 View
510(k) K221089 P12 Elite Series Digital Color Doppler Ultrasound SystemIYN2022-09-15 View
510(k) K221140 P20 Elite Series Digital Color Doppler Ultrasound SystemIYN2022-09-13 View
510(k) K222020 HD-550 Video Endoscope SystemNWB2022-09-08 View
510(k) K211882 HD-550 Video Endoscope SystemNWB2022-04-01 View
510(k) K201059 S60 Elite Series/S70 Series Digital Color Doppler Ultrasound SystemIYN2020-07-30 View
510(k) K182648 X5 Series Digital Color Doppler Ultrasound SystemIYN2019-01-29 View
510(k) K173921 HD-500 Video Endoscope SystemNWB2018-09-05 View
510(k) K172993 P20 Series Digital Color Doppler Ultrasound SystemIYN2017-12-05 View
510(k) K173058 P10 Series Digital Color Doppler Ultrasound SystemIYN2017-12-01 View
510(k) K172082 S60 Series Digital Color Doppler Ultrasound SystemIYN2017-09-21 View
510(k) K170999 P50 Series Digital Color Doppler Ultrasound SystemIYN2017-07-12 View
510(k) K171000 P60 Series Digital Color Doppler Ultrasound SystemIYN2017-07-11 View
510(k) K170303 E5 Series Digital Color Doppler Ultrasound SystemIYN2017-05-19 View
510(k) K163427 X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound SystemIYN2017-01-03 View
510(k) K160283 S45 Digital Color Doppler Ultrasound SystemIYN2016-04-04 View

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