Careray Digital Medical Technology Co., Ltd.
SuZhou Jiangsu, CN
CARERAY DIGITAL MEDICAL TECHNOLOGY CO., LTD. appears in FDA device records in SuZhou Jiangsu, CN. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Careray Digital Medical Technology Co., Ltd. between 2022 and 2023. The busiest year on record is 2022, with 2. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2022 | 2 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232058 | YosemiteView 4343W/YosemiteView 3643W | MQB | Substantially Equivalent | |
| K223687 | X-ray Flat Panel Detectors (EverestView 4343X) | MQB | Substantially Equivalent | |
| K221549 | X-ray Flat Panel Detectors (CareView 1800 RF) | MQB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011158427 | 3011158427 | CARERAY DIGITAL MEDICAL TECHNOLOGY CO., LTD. | No. 15, Songbei Road, Suzhou Industrial Park, SuZhou Jiangsu 215024 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
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