Careray Digital Medical System Co., Ltd.: FDA clearances and approvals
Careray Digital Medical System Co., Ltd. has 10 FDA 510(k) clearances (first 2015, latest 2021), across 1 product code in 1 review panel. Median 510(k) review time: 28 days. Since 2017 its median was 27 days, against 30 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 4 | 70 |
| 2016 | 2 | 30 |
| 2017 | 1 | 29 |
| 2018 | 0 | — |
| 2019 | 1 | 25 |
| 2020 | 1 | 25 |
| 2021 | 1 | 141 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Careray Digital Medical System Co., Ltd.'s cleared 510(k)s took a median 27 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 30 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 10 | 10 |
Review panels
- Radiology (10)
Most recent Careray Digital Medical System Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K202995 | X-ray Flat Panel Detectors/CareView 3600RF | MQB | 2021-02-19 | 141 |
| K201932 | X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) | MQB | 2020-08-07 | 25 |
| K193173 | CareView 1800Le | MQB | 2019-12-13 | 25 |
| K172581 | CareView 1800Cw X-ray Flat Panel Detectors | MQB | 2017-09-26 | 29 |
| K163019 | CareView 750Cw/750C X-ray Flat Panel Detectors | MQB | 2016-12-01 | 31 |
| K162178 | CareView 1500P X-ray Flat Panel Detectors | MQB | 2016-09-01 | 28 |
| K153492 | CareView 1800L | MQB | 2015-12-24 | 20 |
| K153058 | CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors | MQB | 2015-11-10 | 20 |
| K141488 | CAREVIEW 1800R | MQB | 2015-09-08 | 460 |
| K150929 | CareView 1500Cw X-ray Flat Panel Detectors | MQB | 2015-08-04 | 120 |
Recalls
openFDA lists no recalls under a recalling firm named Careray Digital Medical System Co., Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Careray Digital Medical System Co., Ltd. have?
Careray Digital Medical System Co., Ltd. has 10 FDA 510(k) clearances (first 2015, latest 2021), across 1 product code in 1 review panel.
How long does FDA take to clear Careray Digital Medical System Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Careray Digital Medical System Co., Ltd.'s cleared 510(k)s is 28 days. Since 2017: 27 days, versus 30 days for all cleared 510(k)s in the same product codes.
What devices does Careray Digital Medical System Co., Ltd. make?
Its most frequent FDA product codes are MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 10).
Has Careray Digital Medical System Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Careray Digital Medical System Co., Ltd. Related entities may recall under other names.
Next steps
- See all 10 Careray Digital Medical System Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MQB, Careray Digital Medical System Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.