Identifiers
- 510(k) Number
- K201555 FDA 510(k)
- FDA Product Code
- POK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2060 FDA 510(k)
- Regulation Number
- 892.2060 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
EchoGo Pro is a computer-assisted diagnostic software for lesions suspicious for cancer. It is a Class 2 radiology device with product code POK.
EchoGo Pro is supplied as a software platform and is intended for use with stress echo exam protocols containing A2C, A4C and mid-ventricular short-axis views at rest and at peak stress. It has received FDA 510(k) clearance under the traditional pathway (K201555) and is manufactured by Ultromics, Ltd.
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: EchoGo Pro - Ultromics - Health AI Register, K201555 FDA 510(k) - EchoGo Pro | Ultromics, Ltd., EchoGo Pro | Ultromics Ltd radiology AI profile, EchoGo Pro platform Ultromics Ltd. - [LSE] Life-Sciences-Europe.com ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201555 | Class II | Active |
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Manufacturer
- Manufacturer
- Ultromics, Ltd.
Sources (1)
- FDA 510(k) K201555 24 fields · synced Sep 19, 2026