Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005450718

FEI Number

3005450718

Entity Name

RESONANCE HEALTH ANALYSIS SERVICES PTY LTD

City/State/Country

Burswood Western Australia, AU

Establishment Address

141 Burswood Road, Burswood Western Australia 6100, AU

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

RESONANCE HEALTH ANALYSIS SERVICES PTY LTD (Owner Number: 9079481)

Owner / Operator Contact Address

141 Burswood Road, --, Burswood, AU-WA 6100, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN130012

PMA Number

N/A

All Registered Proprietary Names

LiverSmart HepaFatSmart HepaFat-Scan R2-MRI Analysis System (FerriScan)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2024-04-17
PCS	Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox	Radiology	Class 2	892.1001	2024-04-17
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2024-04-17
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2013-12-23
PCS	Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox	Radiology	Class 2	892.1001	2020-11-29

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

RESONANCE HEALTH ANALYSIS SERVICES PTY 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
K033504	General Electric Co.	GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM	2003-11-25
K013636	GE Medical Systems	SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY	2002-01-24
K250443	Siemens Healthcare GmbH	MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile	2025-06-16
K151015	Hitachi Medical Systems America, Inc.	ECHELON Oval V 5.0 MRI System	2015-07-29
K910715	Philips Medical Systems (Cleveland), Inc.	VISTA HPQ SYSTEM	1991-06-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0029-2007	Hitachi Medical Systems America Inc	2	MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J.
Z-0033-2014	Philips Medical Systems (Cleveland) Inc	2	Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications.
Z-0389-2024	Philips North America Llc	2	Achieva 1.5T
Z-0390-2024	Philips North America Llc	2	Achieva 1.5T Conversion
Z-0391-2024	Philips North America Llc	2	Achieva 1.5T Initial System

Similar Registrations

Registration Number	Establishment Name	Location
3019844073	TracInnovations A/S	Ballerup Hovedstaden, DK
3012169560	SIARON MEDICAL LTD	Vancouver British Columbia, CA
3033536331	NEOSCAN SOLUTIONS GMBH	Magdeburg Saxony-Anhalt, DE
3020162557	SPINTECH, INC.	Bingham Farms, MI, US
3012354318	JIANGSU MAGSPIN INSTRUMENT CO., LTD	Kunshan Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005450718. Last updated year: 2026. Please use registration number 3005450718 when referencing this establishment in official correspondence.