Chrysalis Intelligence · Sponsors · Sonoscape Medical Corp.

Sonoscape Medical Corp.

Shenzhen, CN · 10 510(k) clearances

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Total clearances
10
2020-07-30 → 2026-05-15
Last 12 months
2
Product codes
3
Most recent
2026-05-15
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
IYN System, Imaging, Pulsed Doppler, Ultrasonic Class II Radiology 7 2026-05-15
NWB Endoscope, Accessories, Narrow Band Spectrum Class II Gastroenterology, Urology 2 2022-09-08
ODG Endoscopic Ultrasound System, Gastroenterology-Urology Class II Gastroenterology, Urology 1 2024-03-08
Filings

All 510(k) clearances (10)

Date K-number Device Code Class Specialty
2026-05-15 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) IYN Class II Radiology
2025-12-05 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) IYN Class II Radiology
2025-01-17 K241949 Digital Color Doppler Ultrasound System (P60 Series) IYN Class II Radiology
2024-03-08 K231813 Ultrasonic Gastrovideoscope ODG Class II Gastroenterology, Urology
2023-02-10 K222596 S90 Exp Series Digital Color Doppler Ultrasound System IYN Class II Radiology
2022-09-15 K221089 P12 Elite Series Digital Color Doppler Ultrasound System IYN Class II Radiology
2022-09-13 K221140 P20 Elite Series Digital Color Doppler Ultrasound System IYN Class II Radiology
2022-09-08 K222020 HD-550 Video Endoscope System NWB Class II Gastroenterology, Urology
2022-04-01 K211882 HD-550 Video Endoscope System NWB Class II Gastroenterology, Urology
2020-07-30 K201059 S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System IYN Class II Radiology
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence