HeartFlow vs VUNO

VUNO has two openFDA decisions. K231398 covers Med-DeepBrain volumetry of brain MR (October 4, 2023), and K241439 covers chest X-ray triage for adult exams with pleural effusion and/or pneumothorax (November 15, 2024). VUNO's chest page describes screening support for five major findings across lung cancer, tuberculosis and pneumonia, a wider claim than the FDA decision, and says the solution is integrated with PACS without naming a vendor. VUNO's navigation links a US entity site, VUNO MED INC., and VUNO's pages do not say whether the chest triage tool is sold in the US. Its privacy page lists ISO/IEC 27001:2022 certification valid to November 2028. HeartFlow's K213857 (HeartFlow Analysis, October 14, 2022) is tied to Plaque Analysis by the 10-K, and a summary of the 10-K counts 489 US Plaque Analysis accounts at December 31, 2025. Chest films and brain MR on one side and coronary CT angiograms on the other put these tools in front of two services, chest and brain imaging on one side and cardiac CT with revascularization planning on the other.