Intended Use

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.

Technology

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.

Performance

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.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    11/20/2017

    1 month
  • 2

    FDA Approval

    1/12/2018

Other devices from Philips Medical Systems Technologies, Ltd.

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