FDA applicant
Careray Digital Medical System Co., Ltd.
FDA records 10 decisions for Careray Digital Medical System Co., Ltd. (Suzhou, CN) from 2015 to 2021: 10 510(k) clearances. All are in product code MQB (Solid State X-Ray Imager (Flat Panel/Digital…). Since 2016 its 510(k)s took a median of 29 days from receipt to decision, against 39 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 7 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Careray Digital Medical System Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2015.
Planning a device like Careray Digital Medical System Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Careray”
FDA records each applicant name separately; these may or may not be the same firm.