maiLink

maiLink is a PACS and radiology workflow management software available as both a desktop application and web viewer for viewing and assessing DICOM images from various modalities including DX, DR, CR, CT, MR, US, RF, and 2D mammography. It gathers digital images from multiple sources, enables storage, transmission, processing, and visualization within the system or over computer networks, and can optionally integrate with FDA-cleared AI models. The system is designed exclusively for use by proficient and certified medical experts such as physicians, radiologists, and medical technicians.

maiLink shares the same technological principles as its predicate device CARPL in terms of prescription use, support of various imaging modalities, 32-bit color display at 1920×1080 resolution, image storage capability, DICOM standard compliance, and operation features including desktop and web-based interfaces. Both devices support optional integration with external FDA-cleared third-party AI models and provide similar viewing, measurement, and image analysis functions. The main difference is maiLink offers desktop/laptop application capability in addition to web viewer, whereas CARPL is web environment-based only.

NEMA PS 3.1-3.15, 3.18 (2016) for DICOM compliance; IEC 62304:2015 for medical device software life-cycle processes; ISO 14971:2019 for risk management; IEC TR 80002-1:2009 for ISO 14971 application to medical device software; and AAMI TIR57:2016 for medical device security and risk management.

maiLink is substantially equivalent to predicate device CARPL (K232891) because both are Class II medical image management and processing systems with identical product codes (LLZ), nearly identical indications for use, same technical specifications (resolution, storage, DICOM compliance), and overlapping core functions for image viewing and optional AI model integration. The nonclinical testing demonstrated that maiLink meets acceptance criteria for timing of notification, result integrity, and measurement accuracy without introducing new scientific technology, establishing safety and effectiveness equivalent to the predicate device.