Resonance Health Analysis Services Pty, Ltd. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Resonance Health Analysis Services Pty, Ltd. - FDA 510(k) Cleared Dev...
Recent clearances: HepaFatSmart (V2.0.0), LiverSmart, HepaFat-AI
7
Total
6
Cleared
1
Denied
Resonance Health Analysis Services Pty, Ltd. has 6 FDA 510(k) cleared medical devices. Based in Irvine, US.
Last cleared in 2023. Active since 2011. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by Resonance Health Analysis Services Pty, Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Emergo Global Representation, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Resonance Health Analysis Services Pty, Ltd.
7 devices
Cleared
Jun 20, 2023
HepaFatSmart (V2.0.0)
Radiology
32d
Cleared
Dec 29, 2021
LiverSmart
Radiology
27d
Cleared
Dec 07, 2020
HepaFat-AI
Radiology
231d
Cleared
Nov 30, 2018
FerriSmart Analysis System
Radiology
107d
Cleared
Dec 13, 2013
HEPAFAT SCAN
Radiology
520d
Not Cleared
Jan 23, 2013
FERRISCAN R2-MRI ANALYSIS SYSTEM
Radiology
21d
Cleared
Jul 28, 2011
MRI-Q SYSTEM
Radiology
87d