The Illumeo System by Philips Medical Systems Technologies Ltd. is a software platform designed for trained professionals such as radiologists. It manages, processes, and displays medical images and associated patient data from various imaging modalities, supporting visualization, measurements, and tracking changes over time. It enhances workflow through integration with clinical systems and provides advanced viewing tools including 2D/3D views and enterprise web viewers, helping clinicians efficiently interpret imaging studies.
Illumeo system is an image management system intended to be used by trained professionals, including radiologists. It is a software package used with general purpose computing hardware to acquire, store, distribute, process, and display images and associated data throughout a clinical environment. It performs digital image processing, measurement, manipulation and quantification of images, communication and storage, but is not intended for mammography.
Illumeo is a software package used with general purpose computing hardware that manages images and associated data across clinical environments. It supports multiple imaging modalities, integrates with clinical imaging and non-imaging data sources, and offers advanced features such as 2D/3D viewing, patient context briefing, comparison and synchronization of studies, hanging protocols, and enterprise web-based viewers. It uses standard PACS principles including database, image management, and communication protocols.
The device underwent extensive non-clinical performance testing including risk management, software lifecycle, usability engineering, compliance with DICOM standards, and FDA guidance for software. Verification and validation tests demonstrated compliance with acceptance criteria and conformity with standards, with no new safety or effectiveness concerns. No clinical studies were required.
No predicate devices specified
Submission
11/20/2017
FDA Approval
1/12/2018
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