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
iCAS-LV
HighRAD Ltd.
Authorized purpose: Support trained physicians in visualizing and evaluating physician-identified liver lesions on multi-phase reconstructed CT, including lesion size, shape, position, and change over time; not for standalone diagnosis or patient-management decisions.
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: Support trained physicians in visualizing and evaluating physician-identified liver lesions on multi-phase reconstructed CT, including lesion size, shape, position, and change over time; not for standalone diagnosis or patient-management decisions.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Support trained physicians in visualizing and evaluating physician-identified liver lesions on multi-phase reconstructed CT, including lesion size, shape, position, and change over time; not for standalone diagnosis or patient-management decisions.
- Which images or clinical context are in scope? Modality: CT/CTA Anatomy or clinical context: Liver (physician-identified liver lesions) Input: Multi-phase volume datasets of reconstructed contrast-enhanced CT scans in DICOM format received from PACS, with physician-identified liver lesions; compatible CT vendors and models are subject to the device labeling's DICOM requirements.
- Who uses it? Intended users: Trained physicians, including radiologists and other physicians managing the patient.
- What does the software produce? Output: Quantitative liver-lesion volumes and locations in prior and current scans, lesion diameter and volume, total lesion burden, volume and diameter change over time, existing/new/disappeared lesion labels, RECIST measurements, key slices, and DICOM-transferred processing results.
- What is its most important limitation? Key limitation: The physician must identify lesions and validate or manually correct computed segmentations and matching. Results must not be used in isolation for diagnosis or patient management. The reviewed FDA performance data are based on a retrospective liver-lesion dataset and a dedicated phantom study; local scanner, protocol, interface, and clinical-population compatibility require confirmation.
Clinical takeaway
Clinical role: Support trained physicians in visualizing and evaluating physician-identified liver lesions on multi-phase reconstructed CT, including lesion size, shape, position, and change over time; not for standalone diagnosis or patient-management decisions.
Evidence takeaway
Evidence from the reviewed source record: FDA K231690 reports phantom testing on four scanner platforms and a retrospective standalone analysis of 108 patients from Israel, Italy, and the US, comprising 219 contrast-enhanced CT scans and 2,127 liver lesions. Three radiologists established the lesion ground truth. The reported performance evidence uses DICE, ASSD, SHD, volume, and RECIST measurements and includes volume and longitudinal-change agreement, not a diagnostic-detection endpoint.
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
- Support trained physicians in visualizing and evaluating physician-identified liver lesions on multi-phase reconstructed CT, including lesion size, shape, position, and change over time; not for standalone diagnosis or patient-management decisions.
- Intended users
- Trained physicians, including radiologists and other physicians managing the patient.
- Care setting and population
- Clinical radiology and PACS workflow; the FDA packet does not specify a facility type.
- Workflow role
- Post-acquisition liver-lesion review and longitudinal analysis; the radiologist designates lesions, validates computed segmentations, and can manually correct them before semi-automatic matching and quantification.
- Required input
- Multi-phase volume datasets of reconstructed contrast-enhanced CT scans in DICOM format received from PACS, with physician-identified liver lesions; compatible CT vendors and models are subject to the device labeling's DICOM requirements.
- Output and human action
- Quantitative liver-lesion volumes and locations in prior and current scans, lesion diameter and volume, total lesion burden, volume and diameter change over time, existing/new/disappeared lesion labels, RECIST measurements, key slices, and DICOM-transferred processing results.
- Limitations
- The physician must identify lesions and validate or manually correct computed segmentations and matching. Results must not be used in isolation for diagnosis or patient management. The reviewed FDA performance data are based on a retrospective liver-lesion dataset and a dedicated phantom study; local scanner, protocol, interface, and clinical-population 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
- Multi-phase studies are received from PACS and processing output is transferred back to PACS in DICOM; the device is described as PC-based and self-contained. Exact PACS interfaces, versions, and local compatibility require confirmation.
- Deployment and data flow
- On-premise
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.
ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for iCAS-LV; 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 K231690 reports phantom testing on four scanner platforms and a retrospective standalone analysis of 108 patients from Israel, Italy, and the US, comprising 219 contrast-enhanced CT scans and 2,127 liver lesions. Three radiologists established the lesion ground truth. The reported performance evidence uses DICE, ASSD, SHD, volume, and RECIST measurements and includes volume and longitudinal-change agreement, not a diagnostic-detection endpoint.
- 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.
iCAS-LV regulatory performance study summary
- DesignStand-Alone Performance
- PopulationPopulation described in the exact-submission ACR model card
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K231690
- Samplen=108
- IndependenceIndependence not established
K231690
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 K231690 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 K231690. 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 K231690 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
-
FDA K231690: iCAS-LV
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
-
Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
iCAS-LV model card (K231690)
Scope: intendedUsers, 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 K231690
Scope: postmarketSafety
Research history
-
K231690 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
Alternatives
Related tools to compare
FDA-cleared K252992
CT Rembra RT; CT Areta RT; CT Rembra
Philips Healthcare (Suzhou) Co., Ltd.
CT Rembra RT, CT Areta RT, and CT Rembra support whole-body diagnostic imaging, oncology, radiotherapy planning, interventional, vascular, neurological, cardiovascular, and...
- Modality
- CT/CTA
- Anatomy
- Multi-region
- Decision
- 2026-03-23
FDA-cleared K252970
BriefCase-Triage: CARE Multi-triage CT Body
Aidoc Medical, Ltd.
Adult contrast-enhanced and non-contrast CT triage for 11 chest, abdominal, and pelvic findings: diverticulitis, abdominal-pelvic abscess, appendicitis, intestinal...
- Modality
- CT/CTA
- Anatomy
- Chest, Abdomen, and Pelvis
- Decision
- 2026-01-07
FDA-cleared K252029
AI-CVD
HeartLung Corporation
AI-CVD provides automated quantitative CT-derived anatomical and density measurements for clinician review, including calcium scores, cardiac and vascular measurements, lung and...
- Modality
- CT/CTA
- Anatomy
- Chest, abdomen, heart, lungs, liver, aorta, pulmonary artery, bone, muscle, and fat
- Decision
- 2025-12-19
FDA-cleared K242624
Medical Image Post-processing Software (uOmnispace.CT)
Shanghai United Imaging Healthcare Co., Ltd.
uOmnispace.CT provides healthcare institutions with tools to view, manipulate, evaluate, and analyze medical CT images, including colon, lung, vessel, brain, cardiac, liver, rib,...
- Modality
- CT/CTA
- Anatomy
- Colon, lungs and airway, vessels, brain, heart, liver, ribs, spine, and other CT regions
- Decision
- 2025-05-14