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
HealthFLD
Nano-X AI Ltd.
Authorized purpose: Provide quantitative and qualitative liver analysis and mean attenuation measurement to support clinician evaluation and assessment of fatty liver in patients aged 18-75 whose CT includes a significant part of the liver; not for diagnosis or risk assessment of fatty liver disease.
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 and qualitative liver analysis and mean attenuation measurement to support clinician evaluation and assessment of fatty liver in patients aged 18-75 whose CT includes a significant part of the liver; not for diagnosis or risk assessment of fatty liver disease.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Provide quantitative and qualitative liver analysis and mean attenuation measurement to support clinician evaluation and assessment of fatty liver in patients aged 18-75 whose CT includes a significant part of the liver; not for diagnosis or risk assessment of fatty liver disease.
- Which images or clinical context are in scope? Modality: CT/CTA Anatomy or clinical context: Liver Input: Non-contrast or contrast CT scans with any clinical indication for patients aged 18-75, including a significant part of the liver; the FDA technology comparison specifies DICOM and axial CT input.
- Who uses it? Intended users: Clinicians.
- What does the software produce? Output: Mean liver attenuation in Hounsfield Units from a region of interest, with up to three ROI annotations and threshold/reference-range indication; the display threshold is below 40 HU for non-contrast or non-portal-venous CT and below 75 HU when portal venous contrast is identified.
- What is its most important limitation? Key limitation: Not intended to diagnose or provide risk assessment for fatty liver disease. The labeled age and liver-coverage requirements apply, and the validation dataset used at least 4 cm of liver from the superior aspect, which is a study inclusion criterion rather than a replacement for the labeled significant-liver-part wording. Local hosting interface and compatibility require confirmation.
Clinical takeaway
Clinical role: Provide quantitative and qualitative liver analysis and mean attenuation measurement to support clinician evaluation and assessment of fatty liver in patients aged 18-75 whose CT includes a significant part of the liver; not for diagnosis or risk assessment of fatty liver disease.
Evidence takeaway
Evidence from the reviewed source record: FDA K233080 reports a retrospective standalone validation of 250 anonymized CT scans from four healthcare institutions, with three US board-certified radiologists establishing ground truth. All 250 cases returned a result. Agreement was 95.98% for the <40 HU versus >=40 HU classification and 98.39% for <50 HU versus >=50 HU; Bland-Altman 95% limits of agreement for liver-density bias were [-7.80 HU, 7.00 HU], within the stated [-10 HU, 10 HU] interval, and portal-venous-phase identification agreement was 95.98%.
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 and qualitative liver analysis and mean attenuation measurement to support clinician evaluation and assessment of fatty liver in patients aged 18-75 whose CT includes a significant part of the liver; not for diagnosis or risk assessment of fatty liver disease.
- Intended users
- Clinicians.
- Care setting and population
- Clinical CT and liver-assessment workflow; the FDA packet does not specify a facility type.
- Workflow role
- DICOM intake validation followed by liver detection/segmentation, ROI attenuation quantification, result transfer to the hosting application, and error-code reporting when processing fails.
- Required input
- Non-contrast or contrast CT scans with any clinical indication for patients aged 18-75, including a significant part of the liver; the FDA technology comparison specifies DICOM and axial CT input.
- Output and human action
- Mean liver attenuation in Hounsfield Units from a region of interest, with up to three ROI annotations and threshold/reference-range indication; the display threshold is below 40 HU for non-contrast or non-portal-venous CT and below 75 HU when portal venous contrast is identified.
- Limitations
- Not intended to diagnose or provide risk assessment for fatty liver disease. The labeled age and liver-coverage requirements apply, and the validation dataset used at least 4 cm of liver from the superior aspect, which is a study inclusion criterion rather than a replacement for the labeled significant-liver-part wording. Local hosting interface and compatibility require confirmation.
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
- DICOM validation receives an imaging study from a hosting application and the IMA Integration feature returns successful analysis results to that application; the exact interface, version, PACS/RIS/EHR compatibility, and deployment model are not established.
- Deployment and data flow
- Vendor documentation pending
The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.
- 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.
ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for HealthFLD; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · checked 2026-09-08Evidence
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
- FDA K233080 reports a retrospective standalone validation of 250 anonymized CT scans from four healthcare institutions, with three US board-certified radiologists establishing ground truth. All 250 cases returned a result. Agreement was 95.98% for the <40 HU versus >=40 HU classification and 98.39% for <50 HU versus >=50 HU; Bland-Altman 95% limits of agreement for liver-density bias were [-7.80 HU, 7.00 HU], within the stated [-10 HU, 10 HU] interval, and portal-venous-phase identification agreement was 95.98%.
- Reported sensitivity
- Research pending
This field has not been curated yet.
- Reported specificity
- Research pending
This field has not been curated yet.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
HealthFLD regulatory performance study summary
- DesignStand-Alone Performance
- PopulationAdult
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K233080
- Samplen=250
- Sites4
- IndependenceIndependence not established
K233080
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 K233080 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 K233080. 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 deployment and data flow: The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.
- 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 K233080 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
22Fields 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 K233080: HealthFLD
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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HealthFLD model card (K233080)
Scope: intendedUsers, careSetting, output, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
-
PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K233080
Scope: postmarketSafety
Research history
-
K233080 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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