FDA applicant
Visage Imaging GmbH
FDA records 3 decisions for Visage Imaging GmbH (Berlin, DE) from 2008 to 2021: 3 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and QIH (Automated Radiological Image Processing Software). Its devices cite 5 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Visage Imaging, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Visage Imaging GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2008.
Planning a device like Visage Imaging GmbH’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