Sonoscape Company Limited: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Sonoscape Company Limited” (first 2004, latest 2015), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 85 days. 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 |
|---|---|---|
| 2012 | 1 | 28 |
| 2013 | 7 | 84 |
| 2014 | 1 | 107 |
| 2015 | 4 | 114 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 18 | 18 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 3 | 3 |
| DPS | Electrocardiograph | 1 | 1 |
Review panels
- Radiology (21)
- Cardiovascular (1)
Most recent Sonoscape Company Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K150045 | S30/S40 Digital Color Doppler Ultraound System | IYN | 2015-04-28 | 106 |
| K142714 | S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System | IYN | 2015-01-29 | 129 |
| K142815 | S22 Digital Color Doppler Ultrasound System | IYN | 2015-01-28 | 121 |
| K142710 | S9 Portable Digital Color Doppler Ultrasound System | IYN | 2015-01-05 | 105 |
| K142474 | S12 Digital Color Doppler Ultrasound System | IYN | 2014-12-19 | 107 |
| K132527 | DIGITAL COLOR DOPPLER ULTASOUND SYSTEM | IYN | 2013-11-14 | 94 |
| K131262 | DIGITAL ELECTROCARDIOGRAPHS | DPS | 2013-11-14 | 195 |
| K132768 | S8 EXP PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM | IYN | 2013-10-04 | 30 |
| K131213 | DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM | IYN | 2013-06-21 | 53 |
| K130801 | DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM | IYN | 2013-06-14 | 84 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sonoscape Company Limited.
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 Medical Corp. (26 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sonoscape Company Limited?
FDA lists 22 510(k) clearances under the applicant name “Sonoscape Company Limited” (first 2004, latest 2015), 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 Company Limited?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sonoscape Company Limited is 85 days.
Which FDA product codes appear under Sonoscape Company Limited?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 18); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 3); DPS (Electrocardiograph, 1).
Next steps
- See all 22 Sonoscape Company Limited clearances with predicates and recalls
- Run predicate analysis for product code IYN, Sonoscape Company Limited'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.