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Us2.v2

FDA UDI

Class II (US FDA UDI)

by Eko.ai Pte. Ltd.

Identity

Trade Name
Us2.v2 FDA UDI
Generic Name
Radiology DICOM image processing application software FDA UDI
Device Name
Us2.v2 software is used to process acquired transthoracic cardiac ultrasound images, to analyze and make measurements on images in order to provide automated estimation of several cardiac structural and functional parameters, including left/ right atrial and ventricular linear dimensions, volumes, systolic function and diastolic function, measured by B mode, M mode and Doppler (PW, CW, tissue) modalities. The data produced by this software is intended to be used to support qualified cardiologists, sonographers, or other licensed professional healthcare practitioners for clinical decision-making. Us2.v2 is indicated for use in adult patients. Please note the following limitations: • Poor image capture will lead to poor annotations and subsequent measurements. Multiple image quality algorithms are used to filter out images of poor quality. • Our software complements good patient care and does not exempt the user from the responsibility to provide supervision, clinically review the patient, and make appropriate clinical decisions. • If no gender is present, female referenced guideline values will be used for conclusions. • If Body Surface Area (BSA) is not present, indexed values cannot be provided. • During image acquisition, inappropriate use of the echo machine, use of non-cardiac ultrasound probes, use of suboptimal settings (e.g. gain, contrast, depth), or lack of electrocardiogram capture may lead to lower accuracy of the software. FDA UDI
Model / Reference
2 FDA UDI
Description
Us2.v2 software is used to process acquired transthoracic cardiac ultrasound images, to analyze and make measurements on images in order to provide automated estimation of several cardiac structural and functional parameters, including left/ right atrial and ventricular linear dimensions, volumes, systolic function and diastolic function, measured by B mode, M mode and Doppler (PW, CW, tissue) modalities. The data produced by this software is intended to be used to support qualified cardiologists, sonographers, or other licensed professional healthcare practitioners for clinical decision-making. Us2.v2 is indicated for use in adult patients. Please note the following limitations: • Poor image capture will lead to poor annotations and subsequent measurements. Multiple image quality algorithms are used to filter out images of poor quality. • Our software complements good patient care and does not exempt the user from the responsibility to provide supervision, clinically review the patient, and make appropriate clinical decisions. • If no gender is present, female referenced guideline values will be used for conclusions. • If Body Surface Area (BSA) is not present, indexed values cannot be provided. • During image acquisition, inappropriate use of the echo machine, use of non-cardiac ultrasound probes, use of suboptimal settings (e.g. gain, contrast, depth), or lack of electrocardiogram capture may lead to lower accuracy of the software. FDA UDI

Identifiers

Primary DI / UDI-DI
00860005876815 FDA UDI
510(k) Number
K233676 FDA UDI
FDA Product Code
QIH FDA UDI
GMDN Term
Radiology DICOM image processing application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radiology DICOM image processing application software

Us2.v2 by Eko.ai Pte. Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiology DICOM image processing application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Eko.ai Pte. Ltd.

Sources (1)

  • FDA UDI 4725fbd6-3e9f-4a95-b5ee-8badb8b1737a 34 fields · synced Jun 1, 2026