EchoGo Pro

FDA 510(k) K201555 · Ultromics, Ltd.

Substantially Equivalent

510(k) numberK201555

Submission

Device name
EchoGo Pro
Applicant
Ultromics, Ltd.
Oxford, GB
Received
June 10, 2020
Decision date
December 18, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
POK – Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2060
Specialty
Radiology

Assist users in characterizing lesions identified on acquired medical images

Other 510(k)s with product code POK

510(k)DeviceApplicantDecision
K253884Koios DS (3.8)POK · Traditional Koios Medical, Inc.07/02/2026SE
K261519Sonio SuspectPOK · Special Sonio06/04/2026SE
K254161Automated Aortic Stenosis Software (AutoAS)POK · Traditional GE Medical Systems Ultrasound & Primary Care…03/27/2026SE
K251769RevealAI-LungPOK · Traditional Precision Medical Ventures, Inc. Dba Revealdx01/30/2026SE
K252294Fetal EchoScan (v1.2)POK · Traditional Brightheart12/08/2025SE
K250221StrokeSENS ASPECTS Software ApplicationPOK · Traditional Circle Cardiovascular Imaging, Inc.07/01/2025SE
K251071Fetal EchoScan (v1.1)POK · Special Brightheart05/02/2025SE
K243614Sonio SuspectPOK · Traditional Sonio02/21/2025SE
K243294Brainomix 360 e-ASPECTSPOK · Traditional Brainomix Limited02/14/2025SE
K242130Koios DSPOK · Traditional Koios Medical, Inc.11/15/2024SE

More from Koios Medical, Inc.

510(k)DeviceDecision
K240860EchoGo Amyloidosis (1.0)SDJ · Traditional 11/15/2024SE
K240013EchoGo Heart Failure (2.0)QUO · Traditional 09/23/2024SE
K222463EchoGo Heart FailureQUO · Traditional 11/23/2022SE
K213275EchoGo Core (2.0)QIH · Traditional 12/20/2021SE
K191171EchoGo CoreQIH · Traditional 11/13/2019SE

Questions and answers

When was EchoGo Pro cleared by the FDA?

EchoGo Pro (K201555) received a 510(k) decision of Substantially Equivalent on December 18, 2020, 191 days after the submission was received.

What is the product code of K201555?

The FDA product code is POK – Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer, a Class II (moderate risk) device regulated under 21 CFR 892.2060.