Chison Medical Imaging Co., Ltd.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Chison Medical Imaging Co., Ltd.” (first 2005, latest 2017), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 81 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 | 3 | 81 |
| 2013 | 1 | 86 |
| 2014 | 1 | 110 |
| 2015 | 2 | 87 |
| 2016 | 1 | 42 |
| 2017 | 2 | 112 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Chison Medical Imaging Co., Ltd. took a median 112 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 103 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 10 | 10 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | 2 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
Review panels
- Radiology (13)
Most recent Chison Medical Imaging Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K170870 | Site~Rite Halcyon Diagnostic Ultrasound System | IYN | 2017-07-06 | 105 |
| K170374 | SonoBook Series Diagnostic Ultrasound System | IYN | 2017-06-06 | 119 |
| K162172 | EBit Series Diagnostic Ultrasound System | IYN | 2016-09-14 | 42 |
| K153085 | Q Series Diagnostic Ultrasound System | IYN | 2015-12-21 | 56 |
| K150861 | QBit Series Diagnostic Ultrasound System | IYN | 2015-07-28 | 118 |
| K140364 | CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED AND CONVEX PROBE, PENCIL AND CONVEX PROBE | IYN | 2014-06-02 | 110 |
| K131305 | CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBE | IYN | 2013-08-01 | 86 |
| K121867 | SONOTOUCH SERIES DIAGNOSTIC ULTRASOUND SYSTEMS | IYN | 2012-08-02 | 37 |
| K120801 | CHISON DIAGNOSTIC ULTRASOUND SYSTEM | IYN | 2012-06-14 | 90 |
| K113359 | CHISON DIAGNOSTIC ULTRASOUND SYSTEM,CONVEX PROBE,LINEAR PROBE,TRANSVAGINAL MICRO-CONVEX PROBE | IYN | 2012-02-03 | 81 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Chison Medical Imaging Co., Ltd..
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.
- CHISON Medical Technologies Co., Ltd. (11 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Chison Medical Imaging Co., Ltd.?
FDA lists 13 510(k) clearances under the applicant name “Chison Medical Imaging Co., Ltd.” (first 2005, latest 2017), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Chison Medical Imaging Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Chison Medical Imaging Co., Ltd. is 81 days.
Which FDA product codes appear under Chison Medical Imaging Co., Ltd.?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 10); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 2); ITX (Transducer, Ultrasonic, Diagnostic, 1).
Next steps
- See all 13 Chison Medical Imaging Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code IYN, Chison Medical Imaging Co., Ltd.'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.