Data / Medical devices / China / Careray Digital Medical Technology Co., Ltd.
Careray Digital Medical Technology Co., Ltd.: FDA-registered device maker in SuZhou Jiangsu, China, 13 510(k) clearances
Careray Digital Medical Technology Co., Ltd. is registered with the FDA (registration 3011158427) in SuZhou Jiangsu, China. It lists 2 device types. The FDA files 13 510(k) clearances under its listings, the newest dated August 3, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011158427
- Address
- No. 15, Songbei Road, Suzhou Industrial Park, SuZhou Jiangsu, China, 215024
- Owner or operator
- CareRay Digital Medical Technology Co., Ltd. (10050244)
- Roles
- Manufacturer
- First device listed
- October 25, 2015
- Registered through
- 2026
- Brand names listed
- CareView 1500C X-ray Flat Panel Detectors, CareView 1500Cw X-ray Flat Panel Detectors, CareView 1500Cwe X-ray Flat Panel Detectors, CareView 1500L X-ray Flat Panel Detectors, CareView 1500P X-ray Flat Panel Detectors, CareView 1800Cw X-ray Flat Panel Detectors, CareView 1800Cwe X-ray Flat Panel Detectors, CareView 1800L X-ray Flat Panel Detectors and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 3, 2023 | K232058 | YosemiteView 4343W/YosemiteView 3643W | MQB | Substantially Equivalent | Careray Digital Medical Technology Co., Ltd. | accessdata.fda.gov |
| December 30, 2022 | K223687 | X-ray Flat Panel Detectors (EverestView 4343X) | MQB | Substantially Equivalent | Careray Digital Medical Technology Co., Ltd. | accessdata.fda.gov |
| August 1, 2022 | K221549 | X-ray Flat Panel Detectors (CareView 1800 RF) | MQB | Substantially Equivalent | Careray Digital Medical Technology Co., Ltd. | accessdata.fda.gov |
| February 19, 2021 | K202995 | X-ray Flat Panel Detectors/CareView 3600RF | MQB | Substantially Equivalent | Careray Digital Medical System Co., Ltd. | accessdata.fda.gov |
| August 7, 2020 | K201932 | X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) | MQB | Substantially Equivalent | Careray Digital Medical System Co., Ltd. | accessdata.fda.gov |
| December 13, 2019 | K193173 | CareView 1800Le | MQB | Substantially Equivalent | Careray Digital Medical System Co., Ltd. | accessdata.fda.gov |
| September 26, 2017 | K172581 | CareView 1800Cw X-ray Flat Panel Detectors | MQB | Substantially Equivalent | Careray Digital Medical System Co., Ltd. | accessdata.fda.gov |
| December 1, 2016 | K163019 | CareView 750Cw/750C X-ray Flat Panel Detectors | MQB | Substantially Equivalent | Careray Digital Medical System Co., Ltd. | accessdata.fda.gov |
| September 1, 2016 | K162178 | CareView 1500P X-ray Flat Panel Detectors | MQB | Substantially Equivalent | Careray Digital Medical System Co., Ltd. | accessdata.fda.gov |
| December 24, 2015 | K153492 | CareView 1800L | MQB | Substantially Equivalent | Careray Digital Medical System Co., Ltd. | accessdata.fda.gov |
| November 10, 2015 | K153058 | CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors | MQB | Substantially Equivalent | Careray Digital Medical System Co., Ltd. | accessdata.fda.gov |
| September 8, 2015 | K141488 | CAREVIEW 1800R | MQB | Substantially Equivalent | Careray Digital Medical System Co., Ltd. | accessdata.fda.gov |
| August 4, 2015 | K150929 | CareView 1500Cw X-ray Flat Panel Detectors | MQB | Substantially Equivalent | Careray Digital Medical System Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
- All makers of System, X-Ray, Fluoroscopic, Image-Intensified
Updated August 3, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.