Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.
Clinical fit
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Exact purpose
AIRAscore automatically labels, visualizes and quantifies segmentable brain structures from MR images, replacing manual volume measurement and providing reference-adjusted reports and annotated images for expert physician evaluation.
FDA source Exact FDA submission Checked 2026-09-05
Encapsulated PDF DICOM reports and Secondary Capture annotated images; structure reports include raw/intracranial-volume-relative values and reference percentiles. AIRAscore MS additionally reports white-matter lesion number, volume and juxtacortical/periventricular/infratentorial categories.
FDA source Exact FDA submission Checked 2026-09-05
Incoming MRI must meet technical requirements. Expert physicians evaluate reports and control images. Networks remain static during a software version. The described input is single-time-point T1 with optional FLAIR, not the predicate's CT or longitudinal input scope.
FDA source Exact FDA submission Checked 2026-09-05
The baseline's broad scanner-manufacturer label does not establish compatibility of every scanner/protocol. Current v3.1.0 contraindications are retained separately at family scope.
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
FDA submission
K223180
FDA source Exact FDA submission Checked 2026-08-31
Use these fields to structure a vendor demo, security review, and implementation estimate.
Integration
A DICOM storage SCU sends generated reports to a defined storage SCP, usually the referring physician's PACS; annotated DICOM images support expert inspection.
FDA source Exact FDA submission Checked 2026-09-05
Vendor confirmation Exact FDA submission Checked 2026-09-05
A data-transfer description and current IFU are not a scoped current security attestation for the K223180 deployment.
Training and support
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-09-05
Required physician expertise is established, but exact-release training curriculum and competency/support terms are not.
Monitoring and change control
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-09-05
Editorial acceptance questions concern segmentation quality, DICOM age/sex integrity, failed-input reports and update comparability; no monitoring service is verified.
Current family IFU and operating restrictions
The official v3.1.0-rev2 IFU describes optional DICOM SR reports (disabled by default), error reports to PACS and required physician quality review. It excludes patients under 18 and specified structural brain abnormalities, and cautions against contrast-enhanced input.
product family · checked 2026-09-05
European IFU exported April 16, 2026; no exact K223180 release linkage. These later-release functions and exclusions are not silently assigned to the 2023 clearance.
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Evidence summary
Exact-submission technical validation is described without enough numerical detail for comparative performance. Stored publications remain unresolved version leads.
FDA source Exact FDA submission Checked 2026-09-05
Reviewed sources checked Exact FDA submission Checked 2026-09-05
Disease-detection sensitivity with tested-version and population context was not established from this volumetry summary.
Reported specificity
Not established in reviewed sources
Reviewed sources checked Exact FDA submission Checked 2026-09-05
No numerical disease-detection specificity for K223180 was established.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
K223180 AIRAscore accuracy, reproducibility and software validation
Manufacturer accuracy comparison to manually labeled ground truth, test-retest reproducibility and software validation · Brain MR images across target population and scanner manufacturers; sample details not reported in reviewed summary
exact submission · Tested version: AIRAscore configuration described in K223180 · Sponsor or vendor study
K223180
No numerical performance estimate or independent clinical outcome is inferred.
These are common procurement questions; unknown values remain visible until a source supports them.
Pricing and total cost
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-09-05
Reviewed FDA and vendor IFU material does not establish an exact price, unit, term, minimum commitment or included support.
Reimbursement and coding
Research pending
Needs research Exact FDA submission Checked 2026-09-05
No applicable CMS national/local policy content was reviewed; no coverage or coding determination is made.
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
Not established in reviewed sources
Reviewed sources checked Exact FDA submission Checked 2026-09-04
No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Buyer worksheet
Open questions to take to the vendor
Verify security and privacy controls: A data-transfer description and current IFU are not a scoped current security attestation for the K223180 deployment.
Verify training: Required physician expertise is established, but exact-release training curriculum and competency/support terms are not.
Verify pricing and total cost: Reviewed FDA and vendor IFU material does not establish an exact price, unit, term, minimum commitment or included support.
Verify reimbursement and coding relevance: No applicable CMS national/local policy content was reviewed; no coverage or coding determination is made.
Verify local validation and lifecycle monitoring: Editorial acceptance questions concern segmentation quality, DICOM age/sex integrity, failed-input reports and update comparability; no monitoring service is verified.
Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-05Last searched
20Fields reviewed
11Source classes checked
2Reviewed PubMed leads
0Reviewed trial leads
0Unreviewed FDA recall leads
Stored titles/dates screened: scan-rescan software comparison and CE-certified tool in SPG4 are possible family evidence, but neither metadata record establishes the K223180 release. Live PMID 40813790 was blank; 36543827 returned a browser-check page. No publication or trial result promoted; full-text/version assessment remains unresolved. Stored trial array empty. 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, vendor documentation, literature index, trial registry, stored candidate metadata, stored recall candidates, pubmed, clinical trials, openfda device recall
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