aiCockpit AI Viewer
by Fovia, Inc. 510(k)
Active
510(k) K241546
Overview
The aiCockpit AI Viewer is a software-based diagnostic imaging viewer designed to integrate and display results from multiple AI algorithms in a unified interface. It functions as a universal platform for radiologists to visualize, analyze, and interact with AI-generated insights across various imaging modalities and vendors, enhancing diagnostic workflows.
This cloud-based solution is intended for use in radiology departments and imaging centers, providing a single viewer for AI-driven analysis without requiring additional hardware. Supplied as a software application, it is not classified as a single-use or reusable medical device but is regulated under FDA 510(k) clearance (K241546) as a substantially equivalent diagnostic imaging tool. No sterility or physical size specifications are provided, as it operates entirely within a digital interface.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK241546 | Date26 Feb 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the primary purpose of the aiCockpit AI Viewer in a clinical setting?
The aiCockpit AI Viewer is designed to serve as a unified software platform for radiologists to visualize, analyze, and interact with AI-generated insights across different imaging modalities and vendor systems. It consolidates AI-driven diagnostic outputs into a single interface, streamlining workflows in radiology departments and imaging centers without requiring additional hardware.
Is the aiCockpit AI Viewer a physical device or a software solution, and how is it delivered?
The aiCockpit AI Viewer is a software-based solution, not a physical device. It operates entirely within a digital interface and is delivered as a cloud-based application, meaning it does not require specialized hardware beyond standard radiology workstations.
How is the aiCockpit AI Viewer regulated, and what does that mean for its use?
The aiCockpit AI Viewer is regulated under the FDA’s 510(k) clearance process (K241546) and is classified as substantially equivalent to existing diagnostic imaging tools. This means it has undergone FDA review to ensure safety and effectiveness for its intended use as a diagnostic imaging viewer, but it does not require physical sterility or reuse considerations since it is purely software.
Does the aiCockpit AI Viewer come in different sizes or models, or is it a single unified system?
The aiCockpit AI Viewer is a single, unified software platform and does not have physical sizes or discrete models like hardware devices. Its functionality is consistent across deployments, though customization for specific workflows may be possible through configuration settings within the system.
Since it’s a software solution, does the aiCockpit AI Viewer require any special storage or maintenance beyond standard IT practices?
As a cloud-based application, the aiCockpit AI Viewer relies on standard IT infrastructure for deployment and maintenance. No special storage requirements are specified beyond typical server or cloud hosting needs. Updates and maintenance would follow typical software lifecycle management, ensuring compatibility with existing radiology systems.