TeraRecon Aorta.CT (1.1.0)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K243158 FDA 510(k)
- FDA Product Code
- QIH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
TeraRecon Aorta.CT (1.1.0) is an AI-powered medical device designed for automated segmentation and labeling of key anatomical landmarks in the aorta from contrast-enhanced CT angiography (CTA) scans. It functions as a radiology AI tool, generating 3D visualizations and measurements to assist trained medical professionals in evaluating aortic structures without modifying the original imaging data.
This software is intended for use in radiology settings and operates as a standalone application for post-processing CTA scans. Supplied as a non-sterile, reusable digital solution, it requires no special storage conditions beyond standard IT infrastructure. Authorized under FDA 510(k) clearance (K243158) and MDR compliance, it adheres to radiology-specific regulatory standards for AI-enabled diagnostic aids.
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: TeraRecon Aorta.CT User Guide - 1.1.0, TeraRecon Aorta.CT (1.1.0) | TeraRecon, Inc. radiology AI profile, TeraRecon Aorta.CT (1.1.0) | FDA Radiology AI Device, TeraRecon, Inc.: TeraRecon Aorta.CT (1.1.0) (FDA-cleared AI medical ..., PDF 4309 Emperor Boulevard, Suite 310 Re: K243158 Trade/Device Name ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K243158 | Class II | Active |
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Manufacturer
- Manufacturer
- Terarecon Inc.
- FDA Applicant
- Terarecon,Inc.
Sources (2)
- FDA 510(k) K243158 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026