Resonance Health Analysis Services Pty Ltd radiology AI products

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Radiology AI pricing and total cost of ownership

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FDA-cleared K231459

HepaFatSmart (V2.0.0)

Resonance Health Analysis Services Pty Ltd

Authorized purpose: Provide quantitative volumetric liver fat fraction, proton-density fat fraction, and steatosis grading to support clinical diagnosis and subsequent management decisions for confirmed or suspected fatty liver disease or metabolic syndromes and to aid living-donor liver-transplant assessment and screening, with results interpreted by a trained physician.

Modality: MRI
Anatomy: Liver
Decision: 2023-06-20

Oncology quantification Quantification and segmentation

FDA-cleared K213776

LiverSmart

Resonance Health Analysis Services Pty Ltd

Authorized purpose: Measures liver iron concentration for specified iron-overload and thalassemia/sickle-cell indications; assesses VLFF, PDFF, and steatosis grade for suspected or confirmed fatty liver disease; physician-interpreted results may support weight-loss monitoring and living-donor assessment.

Modality: MRI
Anatomy: Liver
Decision: 2021-12-29

Oncology quantification Quantification and segmentation

FDA-cleared K201039

HepaFat-AI

Resonance Health Analysis Services Pty Ltd

Authorized purpose: HepaFat-AI assesses volumetric liver fat fraction, proton-density fat fraction, and steatosis grade in confirmed or suspected fatty-liver disease, supports monitoring of liver fat during weight loss, and may aid assessment or screening of living liver donors under trained physician interpretation.

Modality: MRI
Anatomy: Liver
Decision: 2020-12-07

Oncology quantification

FDA-cleared K182218

FerriSmart Analysis System

Resonance Health Analysis Services Pty Ltd

Measures R2 and liver iron concentration from MRI scans for specified systemic iron-overload and thalassemia indications.

Modality: MRI
Anatomy: Liver
Decision: 2018-11-30

Oncology quantification Quantification and segmentation