Rapid Obstructive Hydrocephalus, Rapid OH

Rapid OH is an AI/ML-based radiological computer-aided triage and notification software that analyzes non-enhanced CT head images to identify suspected obstructive hydrocephalus in adult patients. The device provides clinicians with priority notifications and compressed preview images for workflow prioritization, assisting with triage decisions while requiring clinicians to review full images per standard of care and not serving as a diagnostic device.

Rapid OH is a non-contrast CT processing module operating within the Rapid Platform that uses artificial intelligence and machine learning to analyze DICOM-formatted head images and generate priority notifications. It produces outputs including notifications, reports, and DICOM secondary capture series distributed via PACS, workstation, email, and mobile channels, with a notification time of approximately 30 seconds.

EN ISO 14971:2019 (R2021) for risk management; IEC 62304:2006 (R2015) for software lifecycle processes; IEC 62366:2015 (R2020) for usability engineering; NEMA PS 3.1-3.20 for DICOM compliance; and 21 CFR 820.20 for verification and validation requirements.

Rapid OH is substantially equivalent to Rapid SDH (K232436) because both devices share identical product code (QAS), regulation (21 CFR 892.2080), input requirements (non-contrast CT head images in DICOM format), technological approach (AI/ML-based triage and notification), contraindications structure, and output mechanisms. While Rapid OH targets obstructive hydrocephalus versus Rapid SDH's subdural hemorrhage, both function identically as workflow prioritization tools with equivalent performance architectures, achieving similar sensitivity/specificity profiles (89.5% sensitivity, 97.6% specificity) and employing the same notification and reporting infrastructure.