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FDA-cleared K253649

Spectral CT Verida Family

Philips Medical Systems Technologies, Ltd.

Authorized purpose: Spectral CT Verida Family supports the labeled spectral CT acquisition, reconstruction, material-map, and professional-interpretation workflow; exact models, protocols, and derived outputs remain submission-specific.

Modality
CT/CTA
Anatomy
Multi-region
Decision
2026-03-27
FDA-cleared K173588

Illumeo System

Philips Medical Systems Technologies, Ltd.

Authorized purpose: Illumeo is an image-management system for 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, including digital image processing, measurement, manipulation, quantification, communication, and storage. It is not to be used for mammography.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Images and associated data represented in the clinical environment; mammography excluded
Decision
2018-01-12