Identifiers
- 510(k) Number
- K233753 FDA 510(k)
- FDA Product Code
- JAK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1750 FDA 510(k)
- Regulation Number
- 892.1750 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The AI-Rad Companion (Pulmonary) is an AI-powered software solution designed for automated analysis of chest computed tomography (CT) scans. It functions as an augmented imaging tool, leveraging machine learning and deep learning algorithms to perform measurements and generate clinical reports from imaging datasets. This device falls under the category of AI-assisted diagnostic software, enhancing workflow efficiency by automating routine post-processing tasks. Its primary purpose is to assist radiologists in interpreting medical images with improved precision and reduced manual effort.
The AI-Rad Companion (Pulmonary) is supplied as software and operates within existing radiology workflows, integrating with imaging systems to process CT scans. It is intended for single-use per imaging session, though the underlying software may be reused across multiple scans. The device is not classified as sterile and does not require special MRI safety considerations. Authorized for use in clinical settings, it holds FDA 510(k) clearance under the Radiology Advisory Committee, with a clearance date of March 21, 2024. No additional regulatory markings or sterility requirements are specified.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: AI-Rad Companion - Siemens Healthineers, AI-Rad Companion - Siemens Healthineers, AI-Rad Companion (Pulmonary) Review: Pricing, FDA Status & Alternatives ..., Siemens Healthcare GmbH: AI-Rad Companion (Pulmonary) (FDA-cleared AI ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233753 | Class II | Active |
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Manufacturer
- Manufacturer
- Siemens Healthcare GmbH
Sources (1)
- FDA 510(k) K233753 24 fields · synced Oct 6, 2026