Sonoscape Medical Corp.: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “Sonoscape Medical Corp.” (first 2015, latest 2026), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 103 days. Since 2017 the median was 123 days, against 101 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 3 | 23 |
| 2016 | 3 | 61 |
| 2017 | 7 | 73 |
| 2018 | 1 | 253 |
| 2019 | 1 | 127 |
| 2020 | 1 | 100 |
| 2021 | 0 | — |
| 2022 | 4 | 151 |
| 2023 | 1 | 168 |
| 2024 | 1 | 261 |
| 2025 | 2 | 158 |
| 2026 | 2 | 200 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sonoscape Medical Corp. took a median 123 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 101 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 22 | 22 |
| NWB | Endoscope, Accessories, Narrow Band Spectrum | 3 | 3 |
| ODG | Endoscopic Ultrasound System, Gastroenterology-Urology | 1 | 1 |
Review panels
Most recent Sonoscape Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| 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) | IYN | 2026-08-24 | 251 |
| 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 | 2026-05-15 | 150 |
| 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 | 2025-12-05 | 119 |
| K241949 | Digital Color Doppler Ultrasound System (P60 Series) | IYN | 2025-01-17 | 198 |
| K231813 | Ultrasonic Gastrovideoscope | ODG | 2024-03-08 | 261 |
| K222596 | S90 Exp Series Digital Color Doppler Ultrasound System | IYN | 2023-02-10 | 168 |
| K221089 | P12 Elite Series Digital Color Doppler Ultrasound System | IYN | 2022-09-15 | 155 |
| K221140 | P20 Elite Series Digital Color Doppler Ultrasound System | IYN | 2022-09-13 | 147 |
| K222020 | HD-550 Video Endoscope System | NWB | 2022-09-08 | 62 |
| K211882 | HD-550 Video Endoscope System | NWB | 2022-04-01 | 284 |
16 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sonoscape Medical Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Sonoscape Company Limited (22 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sonoscape Medical Corp.?
FDA lists 26 510(k) clearances under the applicant name “Sonoscape Medical Corp.” (first 2015, latest 2026), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sonoscape Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sonoscape Medical Corp. is 103 days. Since 2017: 123 days, versus 101 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Sonoscape Medical Corp.?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 22); NWB (Endoscope, Accessories, Narrow Band Spectrum, 3); ODG (Endoscopic Ultrasound System, Gastroenterology-Urology, 1).
Next steps
- See all 26 Sonoscape Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code IYN, Sonoscape Medical Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.