EchoGo Pro
510(k) K201555
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK201555 | Date18 Dec 2020 | StatusActive |
Official records
- FDA 510(k) database K201555
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- POK
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2060
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
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.
Devices cleared under K201555
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| EchoGo Pro | Pro | 05060634690010 | — | On the market |
Similar devices
Other devices filed under FDA product code POK (Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer).
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- EchoSolv As by Echo IQ, Ltd.