Resonance Health Analysis Services Pty L T D

FDA Filings

This page includes the latest FDA filings for Resonance Health Analysis Services Pty L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3005450718
• FEI Number: 3005450718
• Name: Michael van der Woude
• Owner & Operator: RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
• Contact Address: 141 Burswood Road --; Burswood AU-WA Western Australia 6100 AU
• US Agent:
  • Michael van der Woude
  • Emergo Global Representation LLC
  • 512 3279997
  • 512 3279998
  • USAgent@ul.com
• Importing Logistics Registration:
  • Importer: Childrens Hospital of Boston
  • Address: 300 Longwood Avenue ; Boston, MA 02115 UNITED STATES
  • Importer Type: End User
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2500 Bee Cave Road Building 1, Suite 300; Austin, TX 78746 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 09355529000088 RESONANCE HEALTH ANALYSIS SERVICES PTY LTD	R2*/T2* Phantom -	2024-04-25
GUDID 09355529000071 RESONANCE HEALTH ANALYSIS SERVICES PTY LTD	T2CMR Phantom -	2024-04-25
GUDID 09355529000064 RESONANCE HEALTH ANALYSIS SERVICES PTY LTD	T1CMR Phantom (3.0T) -	2024-04-25
GUDID 09355529000033 RESONANCE HEALTH ANALYSIS SERVICES PTY LTD	T1CMR Phantom (1.5T) -	2024-04-25
GUDID 09355529000026 RESONANCE HEALTH ANALYSIS SERVICES PTY LTD	FerriScan Phantom	2024-04-18
GUDID 09355529000002 RESONANCE HEALTH ANALYSIS SERVICES PTY LTD	FerriScan, Cardiac T2*	2023-06-27
GUDID 09355529000040 RESONANCE HEALTH ANALYSIS SERVICES PTY LTD	HepaFat-Scan	2023-06-26
GUDID 09355529000019 RESONANCE HEALTH ANALYSIS SERVICES PTY LTD	HepaFat-AI	2023-06-26
PMN K213776 Resonance Health Analysis Services Pty Ltd	LiverSmart	2021-12-29
PMN K182218 | PCS Michael van der Woude [RESONANCE HEALTH ANALYSIS SERVICES PTY LTD]	FerriSmart	2019-01-14
PMN K182218 Resonance Health Analysis Services Pty Ltd	FerriSmart Analysis System	2018-11-30
PMN K122035 | LNH Michael van der Woude [RESONANCE HEALTH ANALYSIS SERVICES PTY LTD]	HepaFat-Scan	2013-12-23
PMN K122035 RESONANCE HEALTH ANALYSIS SERVICES PTY LTD	HEPAFAT SCAN	2013-12-13
De Novo DEN130012 RESONANCE HEALTH ANALYSIS SERVICES PTY LTD	FERRISCAN R2-MRI ANALYSIS SYSTEM	2013-01-23
PMN K111222 | LLZ Michael van der Woude [RESONANCE HEALTH ANALYSIS SERVICES PTY LTD]	MRI-Q System	2011-12-18
PMN K111222 RESONANCE HEALTH ANALYSIS SERVICES PTY LTD	MRI-Q SYSTEM	2011-07-28
PMN K043271 | LNH Michael van der Woude [RESONANCE HEALTH ANALYSIS SERVICES PTY LTD]	R2-MRI ANALYSIS SYSTEM	2005-11-10