aiCockpit AI Viewer

aiCockpit AI Viewer is web-based software for clinical review of medical images intended for use in General Radiology and other healthcare imaging applications. It displays DICOM images with AI-generated annotations and measurements as overlays, allows physicians to accept, reject, or edit AI findings, and performs 2D/3D image manipulations (MPR, MIP, VR) using a zero-footprint browser interface on standard computing devices.

Both the subject device and predicate (Ramsoft OmegaAI Image Viewer) are server-based, zero-footprint web-based JavaScript applications using common desktop browsers (Edge, Chrome, Safari). Both display DICOM images, support standard viewing tools (pan, zoom, window/level, rotate, scroll), display AI annotations and measurements, and allow physician control over editing and adjustment of AI results. The subject device is a narrower functional subset—limited to radiology and desktop browsers only, whereas the predicate supports multiple specialties and mobile environments.

Not stated in this summary.

The devices are substantially equivalent because they share the same fundamental architecture, intended use in radiology, and core functionality: displaying DICOM images with AI-generated findings and allowing clinicians to review and edit those findings through a browser-based interface. The subject device is essentially a subset of the predicate's functionality (radiology-only, desktop-only), not a technological or functional departure. Software verification and validation testing per FDA guidance was conducted and documented to support equivalent performance.