Careray Digital Medical Technology Co., Ltd.
Manufacturer and brand owner in Suzhou, Jiangsu, China. 2 device types, 2 products catalogued, 3 clearances.
Careray Digital Medical Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers System, X-Ray, Fluoroscopic, Image-Intensified, Solid State X-Ray Imager (Flat Panel/Digital Imager). 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2015.
Registration
| Registered name | CARERAY DIGITAL MEDICAL TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3011158427 |
| FEI number | 3011158427 |
| DUNS | 421333508 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 江苏康众数字医疗科技股份有限公司 |
|---|---|
| Unified social credit code | 913205946617779330 |
| Source | NMPA UDI database |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | No. 15, Songbei Road, Suzhou Industrial Park |
| Postal code | 215024 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | Class 2 | YosemiteView 4343W/ YosemiteView 3643W X-ray Flat Panel Detector, EverestView 4343X X-ray Flat Panel Detector, CareView 1500P X-ray Flat Panel Detectors, CareView 1800Cwe X-ray Flat Panel Detectors, CareView 1500Cwe X-ray Flat Panel Detectors, EXAMVue Duo EV14W and 12 more | 2015 | 13 |
| System, X-Ray, Fluoroscopic, Image-Intensified | Class 2 | YosemiteView 4343W/ YosemiteView 3643W X-ray Flat Panel Detector, EverestView 4343X X-ray Flat Panel Detector, CareView 1800RF X-ray Flat Panel Detector | 2022 | 9 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| X-ray Flat Panel Detector | MQB | 16 |
| X-ray Flat Panel Detectors | MQB | 1 |
Clearances
3 clearances name Careray Digital Medical Technology Co., Ltd. as applicant. 10 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K232058 | 2023-08-03 | MQB | Special | This company |
| K223687 | 2022-12-30 | MQB | Special | This company |
| K221549 | 2022-08-01 | MQB | Traditional | This company |
| K202995 | 2021-02-19 | MQB | Traditional | Careray Digital Medical System Co., Ltd. |
| K201932 | 2020-08-07 | MQB | Special | Careray Digital Medical System Co., Ltd. |
| K193173 | 2019-12-13 | MQB | Special | Careray Digital Medical System Co., Ltd. |
| K172581 | 2017-09-26 | MQB | Special | Careray Digital Medical System Co., Ltd. |
| K163019 | 2016-12-01 | MQB | Special | Careray Digital Medical System Co., Ltd. |
| K162178 | 2016-09-01 | MQB | Special | Careray Digital Medical System Co., Ltd. |
| K153492 | 2015-12-24 | MQB | Special | Careray Digital Medical System Co., Ltd. |
| K153058 | 2015-11-10 | MQB | Special | Careray Digital Medical System Co., Ltd. |
| K141488 | 2015-09-08 | MQB | Traditional | Careray Digital Medical System Co., Ltd. |
| K150929 | 2015-08-04 | MQB | Traditional | Careray Digital Medical System Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2007 |
|---|---|
| Main products | digital X-ray flat panel detectors, radiography panels, mammography products, fluoroscopy systems, dental imaging |
| Export markets | 30+ countries |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.