Sonoscape Medical Corp.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 24
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
| K252498 | Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11 | December 5, 2025 |
| K241949 | Digital Color Doppler Ultrasound System (P60 Series) | January 17, 2025 |
| K231813 | Ultrasonic Gastrovideoscope | March 8, 2024 |
| K222596 | S90 Exp Series Digital Color Doppler Ultrasound System | February 10, 2023 |
| K221089 | P12 Elite Series Digital Color Doppler Ultrasound System | September 15, 2022 |
| K221140 | P20 Elite Series Digital Color Doppler Ultrasound System | September 13, 2022 |
| K222020 | HD-550 Video Endoscope System | September 8, 2022 |
| K211882 | HD-550 Video Endoscope System | April 1, 2022 |
| K201059 | S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System | July 30, 2020 |
| K182648 | X5 Series Digital Color Doppler Ultrasound System | January 29, 2019 |
| K173921 | HD-500 Video Endoscope System | September 5, 2018 |
| K172993 | P20 Series Digital Color Doppler Ultrasound System | December 5, 2017 |
| K173058 | P10 Series Digital Color Doppler Ultrasound System | December 1, 2017 |
| K172082 | S60 Series Digital Color Doppler Ultrasound System | September 21, 2017 |
| K170999 | P50 Series Digital Color Doppler Ultrasound System | July 12, 2017 |
| K171000 | P60 Series Digital Color Doppler Ultrasound System | July 11, 2017 |
| K170303 | E5 Series Digital Color Doppler Ultrasound System | May 19, 2017 |
| K163427 | X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System | January 3, 2017 |
| K160283 | S45 Digital Color Doppler Ultrasound System | April 4, 2016 |
| K160258 | X5 Digital Color Doppler Ultrasound System | April 1, 2016 |