Company ยท CN
Sonoscape Medical Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 2015 to 2026. Name variants (Inc, Corp, punctuation) are merged.
26510(k) clearances (3 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 24, 2026 | K254027 | Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 9 Sonoscape Medical Corp., CN | IYN |
| May 15, 2026 | K254028 | Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV, e-Autra, Autra 75, Autra 85W, Autra Sonoscape Medical Corp., CN | IYN |
| Dec 5, 2025 | K252498 | Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plu Sonoscape Medical Corp., CN | IYN |
| Jan 17, 2025 | K241949 | Digital Color Doppler Ultrasound System (P60 Series) Sonoscape Medical Corp., CN | IYN |
| Mar 8, 2024 | K231813 | Ultrasonic Gastrovideoscope Sonoscape Medical Corp., CN | ODG |
| Feb 10, 2023 | K222596 | S90 Exp Series Digital Color Doppler Ultrasound System Sonoscape Medical Corp., CN | IYN |
| Sep 15, 2022 | K221089 | P12 Elite Series Digital Color Doppler Ultrasound System Sonoscape Medical Corp., CN | IYN |
| Sep 13, 2022 | K221140 | P20 Elite Series Digital Color Doppler Ultrasound System Sonoscape Medical Corp., CN | IYN |
| Sep 8, 2022 | K222020 | HD-550 Video Endoscope System Sonoscape Medical Corp., CN | NWB |
| Apr 1, 2022 | K211882 | HD-550 Video Endoscope System Sonoscape Medical Corp., CN | NWB |
| Jul 30, 2020 | K201059 | S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System Sonoscape Medical Corp., CN | IYN |
| Jan 29, 2019 | K182648 | X5 Series Digital Color Doppler Ultrasound System Sonoscape Medical Corp., CN | IYN |
| Sep 5, 2018 | K173921 | HD-500 Video Endoscope System Sonoscape Medical Corp., CN | NWB |
| Dec 5, 2017 | K172993 | P20 Series Digital Color Doppler Ultrasound System Sonoscape Medical Corp., CN | IYN |
| Dec 1, 2017 | K173058 | P10 Series Digital Color Doppler Ultrasound System Sonoscape Medical Corp., CN | IYN |
| Sep 21, 2017 | K172082 | S60 Series Digital Color Doppler Ultrasound System Sonoscape Medical Corp., CN | IYN |
| Jul 12, 2017 | K170999 | P50 Series Digital Color Doppler Ultrasound System Sonoscape Medical Corp., CN | IYN |
| Jul 11, 2017 | K171000 | P60 Series Digital Color Doppler Ultrasound System Sonoscape Medical Corp., CN | IYN |
| May 19, 2017 | K170303 | E5 Series Digital Color Doppler Ultrasound System Sonoscape Medical Corp., CN | IYN |
| Jan 3, 2017 | K163427 | X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System Sonoscape Medical Corp., CN | IYN |
| Apr 4, 2016 | K160283 | S45 Digital Color Doppler Ultrasound System Sonoscape Medical Corp., CN | IYN |
| Apr 1, 2016 | K160258 | X5 Digital Color Doppler Ultrasound System Sonoscape Medical Corp., CN | IYN |
| Jan 13, 2016 | K152854 | S50 Digital Color Doppler Ultrasound System Sonoscape Medical Corp., CN | IYN |
| Sep 3, 2015 | K152396 | S12 Digital Color Doppler Ultrasound System Sonoscape Medical Corp., CN | IYN |
| Aug 28, 2015 | K152164 | S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System Sonoscape Medical Corp., CN | IYN |
| Aug 26, 2015 | K152165 | S9 Portable Digital Color Doppler Ultrasound System Sonoscape Medical Corp., CN | IYN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||