FDA applicant
Shanghai United Imaging Healthcare Co., Ltd.
FDA records 85 decisions for Shanghai United Imaging Healthcare Co., Ltd. (Shanghai, CN) from 2018 to 2026: 85 510(k) clearances. Most are in product codes LNH (System, Nuclear Magnetic Resonance Imaging) and KPS (System, Tomography, Computed, Emission). Since 2016 its 510(k)s took a median of 133 days from receipt to decision, against 121 for FDA’s reviews in the same codes and years. Its devices cite 101 predicates, 69 of them its own earlier devices. 42 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Shanghai United Imaging Healthcare Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
17in 2025
2026 so far, outlined.
Recalls per year
12in 2026
Class I Class II/III not classified
Planning a device like Shanghai United Imaging Healthcare…’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