aiCockpit AI Viewer
Fovia, Inc.aiCockpit AI Viewer is a stand-alone software for clinicians that allows viewing and interacting with medical images and AI annotations within a web browser. It supports various imaging manipulation tools and 3D rendering, helping radiologists review findings effectively by displaying images alongside clinical documents and reports.
Intended Use
AI Viewer is software for clinical review intended for use in General Radiology and other healthcare imaging applications. It supports display of annotations and measurements on DICOM images and AI software, including 3D MPR, MIP, and VR.
Technology
Stand-alone software as medical device (SAaMD) providing image and related information for reviewing and interacting with AI findings on DICOM images through web browsers (Microsoft Edge, Chrome, Safari). Includes 2D and 3D image manipulation tools and supports zero-footprint web user interface.
Performance
Software validation and verification testing included full regression tests, bug fix verification, and end-to-end full tests to ensure all features function correctly. Testing followed FDA guidance for software in medical devices and cybersecurity management.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/31/2024
9 months - 2
FDA Approval
2/26/2025
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