FDA applicant
Manteia Technologies Co., Ltd.
FDA records 7 decisions for Manteia Technologies Co., Ltd. (Xiamen, CN) from 2023 to 2026: 7 510(k) clearances. Most are in product codes QKB (Radiological Image Processing Software For…) and IYE (Accelerator, Linear, Medical). Since 2016 its 510(k)s took a median of 231 days from receipt to decision, against 140 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 3 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 Manteia Technologies Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like Manteia Technologies 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) Report