Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033588305

FEI Number

3033588305

Entity Name

ECHOIQ LIMITED

City/State/Country

Sydney New South Wales, AU

Establishment Address

L 11 66 Clarence Street, Sydney New South Wales 2000, AU

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

EchoIQ Limited (Owner Number: 10091564)

Owner / Operator Contact Address

Level 11, 66 Clarence Street, Sydney, AU-NSW 2000, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K241245

PMA Number

N/A

All Registered Proprietary Names

EchoSolv AS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
POK	Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer	Radiology	Class 2	892.2060	2024-10-16

Official Correspondent

Dane Brescacin

US Agent Details

Dustin Haines Email: dustin.haines@echoiq.ai Phone: (919) 6245212

Related Public Records

Same Entity

EchoIQ Limited

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
K251769	Precision Medical Ventures, Inc. Dba Revealdx	RevealAI-Lung	2026-01-30

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033588305. Last updated year: 2026. Please use registration number 3033588305 when referencing this establishment in official correspondence.