Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017425832

FEI Number

3017425832

Entity Name

EKO.AI PTE. LTD.

City/State/Country

Singapore Central Singapore, SG

Establishment Address

163 Tras Street, #09-04 Lian Huat Building, Singapore Central Singapore 079024, SG

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

eko.ai pte. ltd. (Owner Number: 10080906)

Owner / Operator Contact Address

163 Tras Street, #09-04 Lian Huat Building, Singapore, SG-NOTA 079024, SG

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250151

PMA Number

N/A

All Registered Proprietary Names

Us2.v1 Us2.v2 Viz Echocardiogram AI Measurements Viz Cardiac Amyloidosis AI Detection Us2.ca

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2021-07-29
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2024-04-17
SDJ	Adjunctive Cardiac Amyloidosis Status Indicator	Cardiovascular	Class 2	870.2200	2026-04-07

Official Correspondent

James Hare

US Agent Details

James Hare Email: jamesotishare@gmail.com Phone: (612) 5165025

Related Public Records

Same Entity

eko.ai pte. ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K242270	Orthofix Srl	OrthoNext Platform System	2024-12-19
K261713	FUJIFILM Healthcare Americas Corporation	Synapse PACS (7.6.0)	2026-06-18
K243647	FUJIFILM Healthcare Americas Corporation	Synapse PACS (7.5)	2025-06-30

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017425832. Last updated year: 2026. Please use registration number 3017425832 when referencing this establishment in official correspondence.