Imagine® Enterprise Suite

Imagine® Enterprise Suite (IES) is a medical image management and processing system that receives, stores, and shares DICOM-compliant medical images from various imaging modalities (X-ray angiography, ultrasound, MRI, CT, PET, SPECT, etc.). It is used for display, visualization, and quantification of medical images after acquisition for post-procedure clinical decision support. The system includes specialized viewer modules (EntViewer, EchoViewer, RadViewer, ZFPViewer) and an AngioQuant module for automatic coronary artery quantification, intended for trained professionals to interpret findings without directly generating diagnoses.

IES is built on the IES PACS DICOM infrastructure, restructured from its predecessor HCP DICOM Net® PACS. Key features include multi-modality support, DICOM compliance, automatic vessel segmentation (using deep learning for coronary arteries), manual editing tools, multiple viewer modules with specialized capabilities, image compression support (JPEG, JPEG 2000, RLE), and cybersecurity controls. The AngioQuant module uses machine learning for coronary vessel segmentation, while other modules (EntViewer, EchoViewer, RadViewer) function on deterministic visualization and measurement without machine learning.

IEC 62304:2006 + A1:2015 (medical device software lifecycle), ANSI AAMI ISO 14971:2019 (risk management), IEC 62366-1:2020 (usability engineering), IEC 82304-1:2016 (health software safety), NEMA PS 3.1–3.20:2023e (DICOM), and FDA Guidance for Content of Premarket Submissions for Software Contained in Medical Devices.

IES is substantially equivalent to primary predicate MPXA-2000 (K222036) and reference predicate Syngo.via View&GO VA40A (K230196) based on identical classification (Class II), same regulatory code and intended use (post-procedure clinical decision support for medical image quantification and visualization), comparable technological features (DICOM compliance, automated segmentation, manual editing, multi-modality support), and non-clinical performance data showing no new safety concerns. The device does not introduce novel hazards and performance testing demonstrates it is as safe and effective as its predicates.