FDA applicant
Shenzhen Sontu Medical Imaging Equipment Co., Ltd.
FDA records 1 decision for Shenzhen Sontu Medical Imaging Equipment Co., Ltd. (Shenzhen, CN) in 2025: 1 510(k) clearance. All are in product code KPR (System, X-Ray, Stationary). Its devices cite 2 predicates, 0 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 Shenzhen Sontu Medical Imaging Equipment Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
Planning a device like Shenzhen Sontu Medical Imaging…’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) Report