JLK-AILink

JLK-AILink is a medical image management and processing software that receives digital images from various sources (CT, MRI, ultrasound, radiography, etc.), stores and communicates them via DICOM standards, and displays them for clinical use. It includes tools for image manipulation, annotation, measurement, and mobile access, designed to support trained healthcare professionals in clinical workflows without providing independent diagnosis. The device is not intended for mammography.

JLK-AILink and its predicate STARPACS™ are both software-based systems for medical image management and processing that receive digital images from multiple imaging modalities, store and communicate images via DICOM standards, and display them across distributed computer networks to support clinical workflows. Both systems serve as supportive tools for image interpretation and management by healthcare professionals rather than providing independent clinical diagnosis.

Not stated in this summary. The document references FDA's Guidance for Industry and FDA staff, 'Content of Premarket Submissions for Device Software Functions' (June 14, 2023), but does not cite specific consensus standards such as ISO, IEC, or ASTM.

Both devices share the same intended purpose (medical image management and processing), serve the same user population (trained healthcare professionals), and employ substantially equivalent technology (DICOM-based software for storing, processing, and displaying images from multiple modalities across distributed networks). The verification and validation testing demonstrated that JLK-AILink's system requirements meet acceptance criteria and are adequate for its intended use, establishing functional equivalence to the predicate device STARPACS™.