Medical Device Manufacturer · US , Irvine , CA

Resonance Health Analysis Services Pty, Ltd. - FDA 510(k) Cleared Dev...

7 submissions · 6 cleared · Since 2011

Recent clearances: HepaFatSmart (V2.0.0), LiverSmart, HepaFat-AI

7
Total
6
Cleared
1
Denied

FDA 510(k) Regulatory Record - Resonance Health Analysis Services Pty, Ltd. Radiology ✕

7 devices
1-7 of 7
Cleared Jun 20, 2023
HepaFatSmart (V2.0.0)
K231459 · LNH
Radiology · 32d
Cleared Dec 29, 2021
LiverSmart
K213776 · PCS
Radiology · 27d
Cleared Dec 07, 2020
HepaFat-AI
K201039 · LNH
Radiology · 231d
Cleared Nov 30, 2018
FerriSmart Analysis System
K182218 · PCS
Radiology · 107d
Cleared Dec 13, 2013
HEPAFAT SCAN
K122035 · LNH
Radiology · 520d
Not Cleared Jan 23, 2013
FERRISCAN R2-MRI ANALYSIS SYSTEM
DEN130012 · PCS
Radiology · 21d
Cleared Jul 28, 2011
MRI-Q SYSTEM
K111222 · LLZ
Radiology · 87d
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