FDA applicant
Ge Vingmed Ultrasound AS
FDA records 11 decisions for Ge Vingmed Ultrasound AS (Horten, NO) from 1999 to 2015: 11 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). Its devices cite 25 predicates, 6 of them its own earlier devices. 9 recalls are linked to its devices.
FDA’s records also spell it “Ge Vingmed Ultrasound”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ge Vingmed Ultrasound AS’s devices, and how often a recall has named them.
FDA decisions per year
2in 2015
2026 so far, outlined.
Recalls per year
1in 2024
Class I Class II/III not classified
Planning a device like Ge Vingmed Ultrasound AS’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