# Sonoscape Medical Corp.

- Location (FDA's records): Shenzhen, CN
- FDA decisions: 26 (2015–2026): 26 510(k) clearances
- Product codes: IYN (22), NWB (3), ODG (1)
- 510(k) review time since 2016: median 106 days, against 83 for FDA's reviews in the same codes and years (5 of 19 faster)
- Predicates its devices cite: 26 (20 its own); citations of its devices by later devices: 23 (20 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Sonoscape Company Limited: 4 (https://510kreport.com/company/sonoscape)
- Olympus Medical Systems Corp.: 1 (https://510kreport.com/company/olympus-medical-systems)
- Pentax of America, Inc.: 1 (https://510kreport.com/company/pentax-of-america)

## Firms that cite its devices most
- Medisono, LLC: 3 (https://510kreport.com/company/medisono)

## Its most-cited devices
- K171000: P60 Series Digital Color Doppler Ultrasound System (2017), cited by 4
- K160283: S45 Digital Color Doppler Ultrasound System (2016), cited by 3
- K222596: S90 Exp Series Digital Color Doppler Ultrasound System (2023), cited by 3
- K170999: P50 Series Digital Color Doppler Ultrasound System (2017), cited by 2
- K160258: X5 Digital Color Doppler Ultrasound System (2016), cited by 2
- K173921: HD-500 Video Endoscope System (2018), cited by 1

## Recent decisions
- K254027: 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) (Aug 24, 2026)
- 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) (May 15, 2026)
- 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) (Dec 5, 2025)
- K241949: Digital Color Doppler Ultrasound System (P60 Series) (Jan 17, 2025)
- K231813: Ultrasonic Gastrovideoscope (Mar 8, 2024)
- K222596: S90 Exp Series Digital Color Doppler Ultrasound System (Feb 10, 2023)
- K221089: P12 Elite Series Digital Color Doppler Ultrasound System (Sep 15, 2022)
- K221140: P20 Elite Series Digital Color Doppler Ultrasound System (Sep 13, 2022)

Source page: https://510kreport.com/company/sonoscape-medical