FDA applicant
Ge Hangwei Medical Systems Co., Ltd.
FDA records 10 decisions for Ge Hangwei Medical Systems Co., Ltd. (Beijing, CN) from 2011 to 2024: 10 510(k) clearances. Most are in product codes JAK (System, X-Ray, Tomography, Computed) and LNH (System, Nuclear Magnetic Resonance Imaging). Since 2016 its 510(k)s took a median of 87 days from receipt to decision, against 112 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 3 of them its own earlier devices. 19 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ge Hangwei Medical Systems Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
2in 2025
Class I Class II/III not classified
Planning a device like Ge Hangwei Medical Systems 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