Clarius vs Infervision

InferRead CT Stroke.AI (K211179, decided August 12, 2021) is one of six Infervision records in openFDA across three applicant names, where FDA lists it as triage and notification and Infervision says it triages hemorrhage on head CT. The others are InferRead Lung CT.AI (K192880 and K240554), InferOperate Suite (K250237 and K260973) and InferCare RECIST (K252261). openFDA lists no 510(k) for the chest X-ray reader InferRead DR Chest under those names. A 2025 PLOS Global Public Health evaluation (PMID 40531944) by independent academic authors, run in Lusaka, Zambia, reported sensitivity of 90.3% and specificity of 39.2% at a 0.12 cut-off for TB screening. Radiology departments and TB screening programs are the audience for that software.

Clarius sells wireless ultrasound that runs on a phone or tablet, and urology and OB clinics are its buyers. Its OB AI (K233955, decided June 14, 2024) measures BPD, HC, AC, FL and CRL, and the vendor's AI page labels several tools "available in select markets." A radiology department reading CT or a TB program screening chest X-rays is not the Clarius buyer, and an OB or urology clinic is not the Infervision buyer.