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
iQ-solutions
Sydney Neuroimaging Analysis Centre Pty Ltd
Authorized purpose: Automatically annotate, visualize, and quantify segmentable brain structures from brain MRI at one time point or longitudinally; longitudinal analysis is limited to the same patient's scans from the same scanner with consistent protocol and contrast at two time points.
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: Automatically annotate, visualize, and quantify segmentable brain structures from brain MRI at one time point or longitudinally; longitudinal analysis is limited to the same patient's scans from the same scanner with consistent protocol and contrast at two time points.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Automatically annotate, visualize, and quantify segmentable brain structures from brain MRI at one time point or longitudinally; longitudinal analysis is limited to the same patient's scans from the same scanner with consistent protocol and contrast at two time points.
- Which images or clinical context are in scope? Modality: MRI Anatomy or clinical context: Brain Input: DICOM brain MRI including pre-contrast T1-weighted scans from single or multiple time points, FLAIR scans from single or multiple time points, and post-contrast T1-weighted scans from a single time point.
- Who uses it? Intended users: Trained professionals in hospitals, imaging centers, and image-processing labs, including qualified radiologists and physicians.
- What does the software produce? Output: PDF quantitative reports, annotated DICOM images and masks with colored overlays, and dynamic webpage reports containing brain and substructure volumes or changes, asymmetry measures, white-matter-hyperintensity volumes, contrast-enhancing hyperintensity volumes, and healthy-cohort comparisons.
- What is its most important limitation? Key limitation: The results are not a diagnostic tool and interpretation remains the responsibility of qualified radiologists or physicians. Longitudinal analysis requires the same scanner, consistent acquisition protocol, and consistent contrast at two time points; cross-sectional and longitudinal results cannot be compared. The device processes brain MRI only, not the predicate's NCCT input, and generated overlays are watermarked for non-diagnostic use.
Clinical takeaway
Clinical role: Automatically annotate, visualize, and quantify segmentable brain structures from brain MRI at one time point or longitudinally; longitudinal analysis is limited to the same patient's scans from the same scanner with consistent protocol and contrast at two time points.
Evidence takeaway
Evidence from the reviewed source record: FDA K231929 reports non-clinical bench verification after development on private and public MRI datasets, with module-specific results including sequence-classification accuracy 100%, brain-extraction Dice 0.982, white-matter-hyperintensity Dice 0.789, contrast-enhancing-lesion Dice 0.790, brain-tissue Dice 0.972, brain-volume-change R2 0.869, WMH-activity R2 0.833, cortical/subcortical segmentation R2 0.833, and substructure-volume-change STD 0.0102. The summary includes an 81-patient comprehensive test set and a 120-scan test-retest dataset, and states that no clinical tests were conducted.
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
- Automatically annotate, visualize, and quantify segmentable brain structures from brain MRI at one time point or longitudinally; longitudinal analysis is limited to the same patient's scans from the same scanner with consistent protocol and contrast at two time points.
- Intended users
- Trained professionals in hospitals, imaging centers, and image-processing labs, including qualified radiologists and physicians.
- Care setting and population
- Hospitals, imaging centers, or image-processing laboratories.
- Workflow role
- Post-acquisition MRI segmentation, annotation, visualization, volume analysis, and longitudinal change analysis, with the user reviewing the returned reports and masks.
- Required input
- DICOM brain MRI including pre-contrast T1-weighted scans from single or multiple time points, FLAIR scans from single or multiple time points, and post-contrast T1-weighted scans from a single time point.
- Output and human action
- PDF quantitative reports, annotated DICOM images and masks with colored overlays, and dynamic webpage reports containing brain and substructure volumes or changes, asymmetry measures, white-matter-hyperintensity volumes, contrast-enhancing hyperintensity volumes, and healthy-cohort comparisons.
- Limitations
- The results are not a diagnostic tool and interpretation remains the responsibility of qualified radiologists or physicians. Longitudinal analysis requires the same scanner, consistent acquisition protocol, and consistent contrast at two time points; cross-sectional and longitudinal results cannot be compared. The device processes brain MRI only, not the predicate's NCCT input, and generated overlays are watermarked for non-diagnostic use.
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
- MRI scans are transmitted from the user's PACS through a medical-image routing or integration platform, and PDF reports plus DICOM results return to PACS or another user-specified radiology software system or database. Specific 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 iQ-solutions; 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 K231929 reports non-clinical bench verification after development on private and public MRI datasets, with module-specific results including sequence-classification accuracy 100%, brain-extraction Dice 0.982, white-matter-hyperintensity Dice 0.789, contrast-enhancing-lesion Dice 0.790, brain-tissue Dice 0.972, brain-volume-change R2 0.869, WMH-activity R2 0.833, cortical/subcortical segmentation R2 0.833, and substructure-volume-change STD 0.0102. The summary includes an 81-patient comprehensive test set and a 120-scan test-retest dataset, and states that no clinical tests were conducted.
- 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.
iQ-solutions 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 K231929
- Samplen=1769
- IndependenceIndependence not established
K231929
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 K231929 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 K231929. 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 K231929 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 K231929: iQ-solutions
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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iQ-solutions model card (K231929)
Scope: intendedUsers, output, 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
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openFDA exact recall query for K231929
Scope: postmarketSafety
Research history
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K231929 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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