FDA-cleared K182218
FerriSmart Analysis System
Resonance Health Analysis Services Pty Ltd
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2018-11-30
Vendor
Resonance Health Analysis Services Pty Ltd
4 FDA-backed listings in this directory.
Claim vendor profile FDA-cleared K201039
HepaFat-AI
Resonance Health Analysis Services Pty Ltd
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2020-12-07
FDA-cleared K213776
LiverSmart
Resonance Health Analysis Services Pty Ltd
Image analysis/processing for Liver using PET/SPECT/Nuclear Medicine.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- Liver
- Decision
- 2021-12-29
FDA-cleared K231459
HepaFatSmart (V2.0.0)
Resonance Health Analysis Services Pty Ltd
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2023-06-20