HeartFlow vs Infervision

Eight openFDA records stand behind HeartFlow, from DEN130045 in 2014 to K250902, decided July 18, 2025, for its coronary CT angiogram analyses. Infervision's product list names InferRead CT Coronary, yet openFDA shows no 510(k) for it under the three Infervision applicant names. For a US hospital starting a cardiac CT service, Infervision loses on that record. Its cleared products include InferRead Lung CT.AI (K192880 in July 2020, K240554 in May 2025) for lung nodules, InferRead CT Stroke.AI (K211179, August 2021) for hemorrhage triage on head CT, InferOperate Suite surgical planning (K250237, K260973) and InferCare RECIST (K252261). Infervision's Lung CT page calls the software PACS and RIS friendly, on-premise or cloud, and names no PACS vendor. Infervision suits a radiology department running a lung nodule pathway or a stroke worklist, and HeartFlow suits the cardiac imaging service reading coronary CTA.