Careray Digital Medical System Co., Ltd.
Campbell, CA, US
Careray Digital Medical System Co., Ltd. appears in FDA device records in Campbell, CA. FDA records list 10 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 10
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 10 510(k) clearances for Careray Digital Medical System Co., Ltd. between 2015 and 2021. The busiest year on record is 2015, with 4. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 4 |
| 2016 | 2 |
| 2017 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K202995 | X-ray Flat Panel Detectors/CareView 3600RF | MQB | Substantially Equivalent | |
| K201932 | X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) | MQB | Substantially Equivalent | |
| K193173 | CareView 1800Le | MQB | Substantially Equivalent | |
| K172581 | CareView 1800Cw X-ray Flat Panel Detectors | MQB | Substantially Equivalent | |
| K163019 | CareView 750Cw/750C X-ray Flat Panel Detectors | MQB | Substantially Equivalent | |
| K162178 | CareView 1500P X-ray Flat Panel Detectors | MQB | Substantially Equivalent | |
| K153492 | CareView 1800L | MQB | Substantially Equivalent | |
| K153058 | CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors | MQB | Substantially Equivalent | |
| K141488 | CAREVIEW 1800R | MQB | Substantially Equivalent | |
| K150929 | CareView 1500Cw X-ray Flat Panel Detectors | MQB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain