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
QyScore Software
Qynapse
Authorized purpose: Automatic labeling, visualization, and volumetric quantification of segmentable brain structures and lesions from MR images, with comparison to reference percentile data; not intended for clinical scenarios requiring evaluation of the number of white matter hyperintensities.
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: Automatic labeling, visualization, and volumetric quantification of segmentable brain structures and lesions from MR images, with comparison to reference percentile data; not intended for clinical scenarios requiring evaluation of the number of white matter hyperintensities.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Automatic labeling, visualization, and volumetric quantification of segmentable brain structures and lesions from MR images, with comparison to reference percentile data; not intended for clinical scenarios requiring evaluation of the number of white matter hyperintensities.
- Which images or clinical context are in scope? Modality: MRI Anatomy or clinical context: Brain structures and lesions, including grey matter, white matter, hippocampus, amygdala, and white matter hyperintensities Input: DICOM MRI data with 3D T1 and T2 FLAIR series from patients aged 20 to 90; T1 processing supports 1.5T and 3T scanners and T2 FLAIR processing supports 3T scanners.
- Who uses it? Intended users: Medical personnel or neuroimaging-trained personnel, with review by a trained physician.
- What does the software produce? Output: Volumetric measurements of brain structures and lesions, segmented color overlays, electronic morphometric/PDF reports, comparisons with a healthy reference population and prior scans when available, and DICOM output viewable on DICOM workstations and PACS.
- What is its most important limitation? Key limitation: The intended use excludes clinical scenarios requiring evaluation of the number of white matter hyperintensities. The described input population is ages 20-90 with specified T1/T2 FLAIR protocols and field strengths, and results must be reviewed by a trained physician. The packet supports Linux and off-the-shelf hardware but does not establish every scanner or local configuration.
Clinical takeaway
Clinical role: Automatic labeling, visualization, and volumetric quantification of segmentable brain structures and lesions from MR images, with comparison to reference percentile data; not intended for clinical scenarios requiring evaluation of the number of white matter hyperintensities.
Evidence takeaway
Evidence from the reviewed source record: FDA performance testing included software verification, validation, human-factors testing, literature-based validation studies stated in the submission, and segmentation-accuracy evaluation. For 3D T1 brain structures, Dice coefficients exceeded 85% for whole-brain regions and ranged from 75% to 85% for subcortical structures. Lesion segmentation on paired 3D T1 and T2 FLAIR sequences reported mean absolute volume difference 3.34 mL over lesion loads from 0.09 mL to 87.65 mL. These are segmentation overlap and volume-difference endpoints, not sensitivity or specificity.
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
- Automatic labeling, visualization, and volumetric quantification of segmentable brain structures and lesions from MR images, with comparison to reference percentile data; not intended for clinical scenarios requiring evaluation of the number of white matter hyperintensities.
- Intended users
- Medical personnel or neuroimaging-trained personnel, with review by a trained physician.
- Care setting and population
- Clinical neuroimaging post-processing workflow; the FDA packet does not specify a facility type.
- Workflow role
- Post-acquisition DICOM pipeline that retrieves 3D T1 and T2 FLAIR data, performs automated brain and lesion segmentation and quantification, generates a report and overlays, and supports trained-physician review and editing.
- Required input
- DICOM MRI data with 3D T1 and T2 FLAIR series from patients aged 20 to 90; T1 processing supports 1.5T and 3T scanners and T2 FLAIR processing supports 3T scanners.
- Output and human action
- Volumetric measurements of brain structures and lesions, segmented color overlays, electronic morphometric/PDF reports, comparisons with a healthy reference population and prior scans when available, and DICOM output viewable on DICOM workstations and PACS.
- Limitations
- The intended use excludes clinical scenarios requiring evaluation of the number of white matter hyperintensities. The described input population is ages 20-90 with specified T1/T2 FLAIR protocols and field strengths, and results must be reviewed by a trained physician. The packet supports Linux and off-the-shelf hardware but does not establish every scanner or local configuration.
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 software retrieves DICOM MRI data from a DICOM server, sends it to an analysis server, and supports DICOM output for DICOM workstations and PACS; it also states integration with leading RIS/PACS systems without establishing a specific product, version, or local compatibility.
- 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.
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 QyScore Software; 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
- FDA performance testing included software verification, validation, human-factors testing, literature-based validation studies stated in the submission, and segmentation-accuracy evaluation. For 3D T1 brain structures, Dice coefficients exceeded 85% for whole-brain regions and ranged from 75% to 85% for subcortical structures. Lesion segmentation on paired 3D T1 and T2 FLAIR sequences reported mean absolute volume difference 3.34 mL over lesion loads from 0.09 mL to 87.65 mL. These are segmentation overlap and volume-difference endpoints, not sensitivity or specificity.
- 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.
QyScore Software regulatory performance study summary
- DesignStand-Alone Performance
- PopulationAdult
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K192531
- IndependenceIndependence not established
K192531
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 K192531 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 K192531. 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 K192531 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
24Fields reviewed
9Source classes checked
2Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains 2 PubMed and 0 ClinicalTrials.gov candidate records. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. The current discovery snapshot contains 2 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 K192531: QyScore Software
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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QyScore Software model card (K192531)
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
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openFDA exact recall query for K192531
Scope: postmarketSafety
Research history
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K192531 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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