Add a protocol, not another product.

Three AI Suite modules are FDA 510(k) cleared: NeuroICH, cleared under K241719 on November 7, 2024; MammoSightAI, cleared under K252954; and CXRDetectAI, cleared under K253751 on July 8, 2026. DenseViewAI and NeuroLVO are in clearance review. Each clearance number applies only to its own module. The MammoSightAI clearance letter, 510(k) summary, and Instructions for Use are published on the AI Suite page, along with the NeuroICH clearance certificate and the CXRDetectAI clearance letter.

NeuroICH flags suspected intracranial hemorrhage on non-contrast head CT with 97.5% sensitivity, and it delivers an alert in under 30 seconds after scan acquisition. It flags and prioritizes suspected hemorrhage cases so they move up the radiologist's worklist. The radiologist reviews every flagged study and makes the final diagnosis.

NeuroICH notifies clinicians in less than 30 seconds after scan acquisition and gives them one-click access to the patient study with real-time navigation and review. Inside RadioViewAI, the AI-Findings feature automatically flags and prioritizes suspicious scans for faster triage; critical findings are flagged in 24 seconds versus 24.5 minutes manually. Standardized outputs include probability scores, localization markers, and confidence levels.

NeuroICH was tested across multiple age groups, genders, and CT scanner manufacturers, including Siemens and Philips, and validated across various slice thicknesses. Its FDA 510(k) clearance, K241719, was granted on November 7, 2024. The module is fully DICOM-compliant for PACS integration. Beyond clearance, SaveLife.AI's FDA framework includes multi-reader performance studies for submissions and post-market surveillance with real-world performance monitoring.

You do not need RadioViewAI; AI Suite deploys either way. It has a dual distribution model: embedded within the RadioViewAI cloud PACS as the AI-Findings and AI-Analysis features, or standalone at facilities that keep their own PACS, connected through the ConnectAI gateway. ConnectAI works with GE, Philips, Siemens, Fujifilm, Sectra, Agfa, Change Healthcare, Intelerad, and any DICOM-compliant system, and offers cloud, on-premise, and hybrid deployment options.

Yes, AI Suite supports integrating third-party AI detection modules alongside SaveLife.AI's own modules. Any DICOM-compatible AI detection model can be onboarded through a standardized API framework, results are normalized into a unified output format of probability scores, localization, and confidence levels, and third-party modules appear in the same workflow as internal ones. Performance monitoring and audit logging apply to all modules equally, so facilities can use AI Suite as a single AI orchestration layer across vendors.

Yes, NeuroICH is available free for all low and middle-income countries (LMICs). It is the same FDA 510(k) cleared module, K241719, that detects intracranial hemorrhage on non-contrast head CT in under 60 seconds with 97.5% sensitivity and notifies clinicians in less than 30 seconds. It integrates with PACS through fully DICOM-compliant interfaces.

AI Suite is HITRUST CSF Certified and HIPAA Compliant, with Business Associate Agreements in place with cloud providers. Data is encrypted with AES-256 at rest and TLS 1.3 in transit, DICOM transfers are secured with DICOM-TLS, and the platform runs on a Zero-Trust architecture with continuous risk monitoring and a 99.41% breach-free rate. Audit trails comply with 21 CFR Part 11.