FDA applicant
Careray Digital Medical Technology Co., Ltd.
FDA records 3 decisions for Careray Digital Medical Technology Co., Ltd. (Suzhou, CN) from 2022 to 2023: 3 510(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 23 days from receipt to decision, against 48 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 2 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 Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
Planning a device like Careray Digital Medical Technology…’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.