14-second CT reports. <60s NeuroICH detection. FDA-cleared.

Yes. RadioViewAI is FDA 510(k) cleared under K260936 as a Class II Medical Image Management and Processing System (product code LLZ, 21 CFR 892.2050), covering image viewing, transmission, storage and visualization. That clearance is for the imaging platform, not for a diagnostic function: RadioViewAI does not perform diagnostic analysis and is not intended to replace a dedicated diagnostic workstation. Separately, three AI Suite detection modules hold their own clearances: NeuroICH under K241719, MammoSightAI under K252954, and CXRDetectAI under K253751. NeuroICH flags suspected intracranial hemorrhage on non-contrast head CT with 97.5% sensitivity and delivers a prioritization alert in under 30 seconds after scan acquisition. Two other modules, DenseViewAI and NeuroLVO, have clearance in review.

RadioViewAI generates a structured radiology report in seconds through its RadReport module: about 14 seconds for a CT, 15 seconds for an X-Ray or MRI, 30 seconds for an ultrasound, and 14 seconds for an echo, 87% faster than traditional reporting. Each report includes findings, impressions, and recommended next steps. On average, radiologists save 12.9 minutes per report and about 3 hours per day.

Yes, RadioViewAI connects to any DICOM-compliant PACS through the ConnectAI integration gateway, with full DICOM PS3.1 to PS3.20 (2024) compliance. Supported vendors include GE Healthcare Centricity, Philips IntelliSpace, Siemens syngo.plaza, Fujifilm Synapse, Sectra IDS7, Agfa Enterprise Imaging, Change Healthcare PACS, and Intelerad InteleOne, over TCP/IP, DICOM over TLS, or HTTP/HTTPS connections. On the EHR side, it integrates with Epic, Cerner, Athenahealth, ModMed, eClinicalWorks, and any HL7/FHIR-compliant system.

RadReport is the AI reporting module inside RadioViewAI, not a separate product. It generates detailed, structured reports in seconds and works with or without an existing PACS integration, so a practice can start AI reporting before any interface project. It is voice enabled, letting radiologists speak their intent instead of using traditional dictation, and it pairs with RadEnhance, which flags missing or unclear details and billing-critical documentation gaps and reflects accepted edits in the report instantly.

Yes, RadioViewAI's AI-Viewer runs on mobile, web, and desktop, with an iOS app, an Android app, and a Chrome extension. Because the platform is cloud based and zero-footprint, radiologists can access high-quality DICOM images on mobile devices without any on-site installation. Critical stroke alerts from the NeuroICH module also reach clinicians as notifications on the go, with customizable search filters for faster patient evaluations.

RadioViewAI is built for multi-site reading: it is a zero-footprint cloud platform with instant, secure access to every site, and radiologists switch between any PACS or DICOM servers through ConnectAI. Work is organized into systems, sites, and users, a single radiologist can be assigned to read for multiple sites, and role-based multisite authentication controls access at each level. This makes it well suited to teleradiology groups that need to rapidly scale reading services.

RadioViewAI offers cloud, on-premise, and hybrid deployment options. The recommended option is the cloud gateway, which requires no on-site hardware; alternatives are an on-premise gateway running as a physical or virtual appliance, or a hybrid setup that performs de-identification on site with processing in the cloud. All data is protected with TLS 1.3 encryption in transit and AES-256 at rest, and the platform is HITRUST CSF Certified and HIPAA Compliant.

RadReport's measured accuracy is 98.5% for the impression section, 97% for clinical history, 96% for comparison, 93% for findings, and 92% for study overview, and the radiologist always reviews and signs the final report. Drafts can be refined with AI tools for structure and clarity before signing. With CareTeam Connect, team members can view and edit a report, but only the report owner holds signing and revoking authority.