# Careray Digital Medical System Co., Ltd.

- Location (FDA's records): Suzhou, CN
- FDA decisions: 10 (2015–2021): 10 510(k) clearances
- Product codes: MQB (10)
- 510(k) review time since 2016: median 29 days, against 39 for FDA's reviews in the same codes and years (5 of 6 faster)
- Predicates its devices cite: 10 (7 its own); citations of its devices by later devices: 9 (7 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Vieworks Co., Ltd.: 1 (https://510kreport.com/company/vieworks)
- Iray Technology (Shanghai), Ltd.: 1 (https://510kreport.com/company/iray-technology-shanghai)
- Canon, Inc.: 1 (https://510kreport.com/company/canon)

## Firms that cite its devices most
- Shanghai PZ Medical Technolgoy Co., Ltd.: 1 (https://510kreport.com/company/shanghai-pz-medical-technolgoy)
- Careray Digital Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/careray-digital-medical-technology)

## Its most-cited devices
- K150929: CareView 1500Cw X-ray Flat Panel Detectors (2015), cited by 4
- K193173: CareView 1800Le (2019), cited by 2
- K153058: CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors (2015), cited by 2
- K153492: CareView 1800L (2015), cited by 1

## Recent decisions
- K202995: X-ray Flat Panel Detectors/CareView 3600RF (Feb 19, 2021)
- K201932: X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) (Aug 7, 2020)
- K193173: CareView 1800Le (Dec 13, 2019)
- K172581: CareView 1800Cw X-ray Flat Panel Detectors (Sep 26, 2017)
- K163019: CareView 750Cw/750C X-ray Flat Panel Detectors (Dec 1, 2016)
- K162178: CareView 1500P X-ray Flat Panel Detectors (Sep 1, 2016)
- K153492: CareView 1800L (Dec 24, 2015)
- K153058: CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors (Nov 10, 2015)

Source page: https://510kreport.com/company/careray-digital-medical-system