LiveMedica Enterprise PACS

LiveMedica Enterprise PACS is a Picture Archiving and Communication System that stores, retrieves, manages, and displays DICOM-compliant medical images for diagnostic imaging workflows across hospitals and healthcare networks. It is intended for use by trained healthcare professionals to view, process, and archive medical images, supporting physicians in diagnosis while maintaining that the final diagnostic decision remains with the doctor.

The device uses DICOM 3.0 format, server-side image rendering, and Windows operating system, with support for multiple imaging modalities (CR, CT, DR, DX, ES, ECG, GM, IO, MG, MR, NM, PT, OT, RF, RT, US, XA, XC). It provides similar image manipulation functions (zoom, pan, window/level, MPR, MIP, fusion) and measurement tools (distance, angulation, area, 3D visualization) as the predicate, with comparable hardware and software requirements.

The device was developed per IEC 62304:2015 (medical device software lifecycle) and ISO 14971:2019 (risk management), meets NEMA PS 3.1-3.20 (DICOM radiology standard) and ISO IEC 10918-1 (image compression), and underwent verification and validation testing per FDA guidance documents on device software functions (June 2023) and cybersecurity in medical devices (June 2025).

LiveMedica Enterprise PACS is substantially equivalent to the predicate VISAGE PACS 6.0/CS 3.1 (K082269) based on identical intended use and indications for use, same product code and regulatory classification, and substantially similar technological characteristics including image processing methods, supported modalities, and manipulation/measurement functions. Testing shows the device does not raise new safety or efficacy concerns compared to the predicate.