Input or output interoperability
DICOM is explicitly referenced in the described input, output, or workflow.
exact submission · checked 2026-09-01The model card does not establish every supported DICOM object, transfer method, or local interface.
FDA-cleared profile
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.
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
Product overview
Start with the essentials
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.
Overview status: Source-reviewed overview
- What does this software do? 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.
- Which images or clinical context are in scope? Modality: MRI Anatomy or clinical context: Liver Input: DICOM MRI datasets acquired according to the HepaFatSmart/HepaFat-Scan protocol using the specified gradient-recalled-echo approach, for patients of all populations independent of age and gender with suspected clinical conditions related to liver fat.
- Who uses it? Intended users: Trained physicians; the FDA report requires physician interpretation and includes radiologist review of the liver ROI and result.
- What does the software produce? Output: PDF and DICOM secondary-capture reports containing VLFF, PDFF, steatosis grade, associated confidence intervals and normal range, two echo-time images, a predicted liver ROI overlay, and a fat-distribution map; Alpha is converted into the reported VLFF, PDFF, and steatosis grade.
- What is its most important limitation? Key limitation: The specified MRI protocol and protocol-quality checks are critical to the reported results, and the FDA validation included an excessive-iron assessment that rejected one repeatability case and caused 281 of 300 validation subjects to pass the IQC rules. Results require trained-physician interpretation and clinical context; the packet does not establish unrestricted MRI-sequence or population performance.
Clinical takeaway
Clinical role: 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.
Evidence takeaway
Evidence from the reviewed source record: The FDA packet reports a repeatability study of 42 paired subjects, with 41 used for HepaFatSmart after one high-iron case was rejected, and a validation study of 300 subjects in which 281 passed IQC. For VLFF values above 4.1%, sensitivity was 100.0% (95% CI 97.3%-100.0%) and specificity 98.6% (94.9%-99.6%); above 12.1%, sensitivity 98.8% (93.6%-99.8%) and specificity 98.0% (94.9%-99.2%); above 16.2%, sensitivity 100.0% (93.8%-100.0%) and specificity 99.6% (97.5%-99.9%). Bland-Altman bias, limits of agreement, and repeatability coefficients are separate quantitative-agreement endpoints.
Clinical details
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
- Exact 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.
- Intended users
- Trained physicians; the FDA report requires physician interpretation and includes radiologist review of the liver ROI and result.
- Care setting and population
- Clinical liver MRI workflow for suspected or confirmed fatty liver conditions, metabolic syndromes, lifestyle-management support, and living-donor screening; the FDA packet does not specify a facility type.
- Workflow role
- Post-acquisition MRI protocol-quality checking and automated liver ROI/image analysis followed by report review in clinical context.
- Required input
- DICOM MRI datasets acquired according to the HepaFatSmart/HepaFat-Scan protocol using the specified gradient-recalled-echo approach, for patients of all populations independent of age and gender with suspected clinical conditions related to liver fat.
- Output and human action
- PDF and DICOM secondary-capture reports containing VLFF, PDFF, steatosis grade, associated confidence intervals and normal range, two echo-time images, a predicted liver ROI overlay, and a fat-distribution map; Alpha is converted into the reported VLFF, PDFF, and steatosis grade.
- Limitations
- The specified MRI protocol and protocol-quality checks are critical to the reported results, and the FDA validation included an excessive-iron assessment that rejected one repeatability case and caused 281 of 300 validation subjects to pass the IQC rules. Results require trained-physician interpretation and clinical context; the packet does not establish unrestricted MRI-sequence or population performance.
Regulatory identity
FDA record and catalog context
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- The FDA description states that users upload DICOM images to the FAST portal/job-management system and that HepaFatSmart can be accessed through cloud-based, onsite, or third-party platforms, with PDF and DICOM secondary-capture reports; exact current interfaces, hosting configuration, and local compatibility are not established.
- Deployment and data flow
- On-cloud
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
- Security and privacy
- Vendor documentation pending
Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Training and support
- Vendor documentation pending
Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Monitoring and change control
- Vendor documentation pending
Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
Supported acquisition environment
Scanner manufacturers: All
exact submission · checked 2026-09-01Confirm currently supported software versions, protocols, and site-specific acquisition configurations.
ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for HepaFatSmart (V2.0.0); FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · checked 2026-09-09Evidence
Performance evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.
- Evidence summary
- The FDA packet reports a repeatability study of 42 paired subjects, with 41 used for HepaFatSmart after one high-iron case was rejected, and a validation study of 300 subjects in which 281 passed IQC. For VLFF values above 4.1%, sensitivity was 100.0% (95% CI 97.3%-100.0%) and specificity 98.6% (94.9%-99.6%); above 12.1%, sensitivity 98.8% (93.6%-99.8%) and specificity 98.0% (94.9%-99.2%); above 16.2%, sensitivity 100.0% (93.8%-100.0%) and specificity 99.6% (97.5%-99.9%). Bland-Altman bias, limits of agreement, and repeatability coefficients are separate quantitative-agreement endpoints.
- Reported sensitivity
- FDA VLFF-threshold sensitivity in the IQC-passing validation set (n=281): VLFF >4.1% 100.0% (95% CI 97.3%-100.0%); VLFF >12.1% 98.8% (93.6%-99.8%); VLFF >16.2% 100.0% (93.8%-100.0%).
The FDA values are threshold-specific sensitivity for predicting HepaFat-Scan VLFF values, not a generic 90% device metric or a clinical-outcome endpoint.
- Reported specificity
- FDA VLFF-threshold specificity in the IQC-passing validation set (n=281): VLFF >4.1% 98.6% (95% CI 94.9%-99.6%); VLFF >12.1% 98.0% (94.9%-99.2%); VLFF >16.2% 99.6% (97.5%-99.9%).
The FDA values are threshold-specific specificity for predicting HepaFat-Scan VLFF values; Bland-Altman and repeatability results remain separate.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
HepaFatSmart (V2.0.0) regulatory performance study summary
- DesignStand-Alone Performance
- PopulationAdult and Pediatric
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K231459
- Samplen=300
- IndependenceIndependence not established
K231459
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
Costs and setup
Budget and ongoing governance
These are common procurement questions; unknown values remain visible until a source supports them.
- Pricing and total cost
- Vendor documentation pending
No public price or quote for the exact K231459 configuration was established in this review.
- Reimbursement and coding
- Not established in reviewed sources
No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
Safety and lifecycle
Postmarket record
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
- Postmarket safety review
- The exact-identifier FDA recall query returned no native recall record for K231459. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
Buyer worksheet
Open questions to take to the vendor
- Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Verify pricing and total cost: No public price or quote for the exact K231459 configuration was established in this review.
- Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
- Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Exact FDA record reviewedStatus
2026-09-20Last searched
26Fields reviewed
9Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.
Source classes: fda ai list, fda decision summary, acr ai central product, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources & history
How this profile was documented
Open the ledger for source dates, scope, and research-record updates.
View source ledger and history
Source ledger
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FDA K231459: HepaFatSmart (V2.0.0)
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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HepaFatSmart (V2.0.0) model card (K231459)
Scope: intendedUsers, careSetting, output, limitations, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
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PubMed biomedical literature index
Scope: evidenceDiscovery
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ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K231459
Scope: postmarketSafety
Research history
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K231459 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
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