QuickRad

QuickRad is a web-based Picture Archiving and Communication System (PACS) designed for use in radiology centers, diagnostic labs, and hospitals. It receives, stores, transmits, processes, and displays medical images from DICOM-compliant sources (CT, MRI, ultrasound, X-ray) and allows distributed access across computer networks. The system optionally integrates FDA-cleared third-party AI models and displays their outputs as-is, with AI safety and effectiveness covered under the original manufacturer's clearance.

QuickRad shares the same regulation (21 CFR 892.2050), device class (Class II), and product code (LLZ) as the predicate device Augmento. Both are web-based PACS systems with similar core functions including image storage, transmission, processing, display, DICOM compliance, 3D visualization (MPR/MIP), measurement tools, reporting capabilities, and optional FDA-cleared AI model integration. The key difference is that Augmento includes a sharpening feature absent in QuickRad, but QuickRad adds features such as synchronized screening, cine/movie mode, and overlay capabilities that Augmento does not have.

ISO 13485:2016 (Quality Management Systems), IEC 62304:2015 (Software lifecycle processes), IEC 62366-1:2015 (Usability engineering), ISO 14971:2019 (Risk management), NEMA PS 3.1-3.20 2023e (DICOM), and IEC ISO 10918-1:1994 (Digital image compression). Testing included unit, integration, and system testing; hazard analysis and risk mitigation; vulnerability assessment and penetration testing (VAPT); usability testing; and measurement studies against the FDA-cleared FlexView Diagnostic DICOM Viewer (K233226).

QuickRad is substantially equivalent to Augmento because both devices have identical intended uses, regulatory classifications, and core principles of operation as medical image management and processing systems. The technological characteristics are substantially similar in all material respects: both support multiple imaging modalities, DICOM compliance, image storage and transmission, viewing and processing functions, measurement tools, and optional FDA-cleared AI integration. Non-clinical performance testing demonstrated that QuickRad's measurement tools (angles, lengths, ROI) perform equivalently to an FDA-cleared predicate viewer. The absence of Augmento's sharpening feature does not create new safety or effectiveness concerns, as QuickRad maintains robust diagnostic functionality through alternative visualization techniques.