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FDA-cleared K241546

aiCockpit AI Viewer

Fovia, Inc.

Authorized purpose: aiCockpit AI Viewer displays DICOM and AI images with annotations, measurements, three-dimensional reformats, and reports for trained healthcare professionals; the physician retains the final clinical interpretation.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Multi-region anatomy represented in general-radiology and other healthcare imaging studies
Decision
2025-02-26