Identifiers
- 510(k) Number
- K240013 FDA 510(k)
- FDA Product Code
- QUO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2200 FDA 510(k)
- Regulation Number
- 870.2200 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
EchoGo Heart Failure (2.0) is an Adjunctive Heart Failure Status Indicator, an AI-powered medical device designed to assist in the detection and assessment of heart failure with preserved ejection fraction (HFpEF) from echocardiogram scans. It functions as a diagnostic aid by analyzing echocardiographic data to provide supplementary insights, helping clinicians refine diagnostic certainty and guide clinical decision-making.
The device is supplied as a software-based solution, intended for use in clinical settings where echocardiograms are performed. It operates as a single-use application per scan analysis, with no requirement for sterilization or physical handling, and is classified under FDA regulation 870.2200 as a Class II device. Storage and use adhere to standard IT and medical imaging infrastructure protocols, with no specific MRI safety considerations noted. Authorized for marketing in the US via FDA 510(k) clearance (K240013, decision date 2024-09-23)
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: HFpEF Detection From Echo Scans | Augmentative Intelligence | Echogo ..., EchoGo | AI for detection of HFpEF & Cardiac Amyloidosis | Ultromics, Ultromics Limited: EchoGo Heart Failure (2.0) (FDA-cleared AI medical ..., EchoGo Heart Failure (2.0) (K240013) - FDA 510 (k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240013 | Class II | Active |
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Manufacturer
- Manufacturer
- Ultromics Limited
Sources (1)
- FDA 510(k) K240013 24 fields · synced Sep 19, 2026