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Sydney Neuroimaging Analysis Centre Pty Ltd: FDA-registered device maker in Camperdown New South Wales, Australia, 1 510(k) clearance

Name: Sydney Neuroimaging Analysis Centre Pty Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Sydney Neuroimaging Analysis Centre Pty Ltd is registered with the FDA (registration 3017058304) in Camperdown New South Wales, Australia. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 18, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3017058304
Address: Lvl 1, 94 Mallett Street, Camperdown New South Wales, Australia, 2050
Owner or operator: Sydney Neuroimaging Analysis Centre PTY LTD (10075724)
Roles: Manufacturer
First device listed: June 25, 2020
Registered through: 2026
Brand names listed: Torana Medical Imaging Gateway, iQ-Solutions

Devices it lists

Device	Product code	Class	Role	Source
Automated Radiological Image Processing Software	QIH	2	Manufacturer	accessdata.fda.gov
System, Digital Image Communications, Radiological	LMD	1	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 18, 2023	K231929	iQ-solutions	QIH	Substantially Equivalent	Sydney Neuroimaging Analysis Centre Pty, Ltd.	accessdata.fda.gov

Compare with other makers

Updated December 18, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.