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Us2.v1

by Eko.Ai Pte Ltd. D/B/A Us2.Ai

510(k) K210791Ref DOC015Model v1

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K210791↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0860005876801UZ Basic UDI-DI 00860005876808UDI-DIDate13 May 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00860005876808 UDI-DI Date16 Nov 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK210791 Date27 Jul 2021ClearedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Generic Name
Radiology DICOM image processing application software
Model / Reference
v1 EUDAMED
DOC015 EUDAMED
1 GUDID
Primary DI / UDI-DI
00860005876808
Basic UDI-DI
0860005876801UZ
510(k) Number
FDA Product Code
QIH
EMDN Code
Z12050592 Cardiac output measurement instruments - medical device software
GMDN Term
Radiology DICOM image processing application software
Device Class
Class IIb EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 892.2050
Special Device Type
Software
EU market of registration
Netherlands
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 2 fields differ

FieldEUDAMED510(k)GUDID
Model / ReferenceEUDAMED
v1
DOC015
510(k)
—
GUDID
1
Device ClassEUDAMED
Class IIb
510(k)
Class II
GUDID
Class II

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Us2.v1 is a cardiac ultrasound image analysis software designed to automatically process and analyze transthoracic echocardiogram images. It generates structured reports with quantitative measurements of key cardiac structural and functional parameters, including left ventricular dimensions and ejection fraction.

This software is intended for use by qualified cardiologists or licensed primary care providers to assist in diagnostic interpretation. Supplied as a digital platform, it requires no physical sterilization or single-use considerations. The device is FDA 510(k) cleared under the Radiology advisory committee and meets MDR requirements. No physical sizes or storage conditions are specified beyond standard IT infrastructure requirements.

Other devices from Eko.Ai Pte Ltd. D/B/A Us2.Ai

  • Us2.ca

    Class II

  • Us2.v2

    Class II

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of healthcare providers are authorized to use this software for diagnostic interpretation?

    The software is designed for use by qualified cardiologists or licensed primary care providers to assist in interpreting transthoracic echocardiogram images. It is not intended for use by non-medical personnel or unlicensed clinicians.

  • How is this device supplied, and are there any physical sterilization or single-use requirements?

    Us2.v1 is supplied as a digital platform, meaning it is not a physical device requiring sterilization or single-use considerations. It operates entirely on IT infrastructure, so no physical handling or sterilization protocols apply.

  • What specific cardiac measurements does this software automatically generate in its reports?

    The software automatically processes echocardiogram images to generate structured reports with quantitative measurements of key cardiac parameters, including left ventricular dimensions and ejection fraction.

  • What regulatory pathways has this device undergone, and which advisory committee was involved?

    Us2.v1 has undergone FDA 510(k) clearance through the Radiology advisory committee (RA) and meets MDR (Medical Device Regulation) requirements. The clearance was determined to be substantially equivalent under the Radiology product code category.

  • Does this software require any special storage conditions beyond standard IT infrastructure?

    No specific storage conditions are mentioned beyond standard IT infrastructure requirements. Since it is a digital platform, typical server or cloud storage conditions apply, assuming compliance with data security and backup protocols.

Properties

  • Measuring Function
  • Serial Number

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No