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Resonance Health Analysis Services Pty Ltd: FDA-registered device maker in Burswood Western Australia, Australia, 7 510(k) clearances

Name: Resonance Health Analysis Services Pty Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Resonance Health Analysis Services Pty Ltd is registered with the FDA (registration 3005450718) in Burswood Western Australia, Australia. It lists 4 device types. The FDA files 7 510(k) clearances under its listings, the newest dated June 20, 2023. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3005450718
Address: 141 Burswood Road, Burswood Western Australia, Australia, 6100
Owner or operator: RESONANCE HEALTH ANALYSIS SERVICES PTY LTD (9079481)
Roles: Manufacturer
First device listed: November 10, 2005
Registered through: 2026
Brand names listed: Cardiac T2*, FerriScan, FerriScan Phantom, FerriSmart, HepaFat-Scan, HepaFatSmart, LiverSmart, R2*/T2* Phantom and more

Devices it lists

Device	Product code	Class	Role	Source
Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox	PCS	2	Manufacturer	accessdata.fda.gov
Phantom, Anthropomorphic, Radiographic	IXG	1	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov
System, Nuclear Magnetic Resonance Imaging	LNH	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
June 20, 2023	K231459	HepaFatSmart (V2.0.0)	LNH	Substantially Equivalent	Resonance Health Analysis Services Pty, Ltd.	accessdata.fda.gov
December 29, 2021	K213776	LiverSmart	PCS	Substantially Equivalent	Resonance Health Analysis Services Pty, Ltd.	accessdata.fda.gov
November 30, 2018	K182218	FerriSmart Analysis System	PCS	Substantially Equivalent	Resonance Health Analysis Services Pty, Ltd.	accessdata.fda.gov
December 13, 2013	K122035	HEPAFAT SCAN	LNH	Substantially Equivalent	Resonance Health Analysis Services Pty, Ltd.	accessdata.fda.gov
January 23, 2013	DEN130012	FERRISCAN R2-MRI ANALYSIS SYSTEM	PCS	Unknown	Resonance Health Analysis Services Pty, Ltd.	accessdata.fda.gov
July 28, 2011	K111222	MRI-Q SYSTEM	LLZ	Substantially Equivalent	Resonance Health Analysis Services Pty, Ltd.	accessdata.fda.gov
January 21, 2005	K043271	R2-MRI ANALYSIS SYSTEM	LNH	Substantially Equivalent	Inner Vision Biometrics Pty, Ltd.	accessdata.fda.gov

Compare with other makers

Updated June 20, 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.