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: Brain midline-shift measurement on adult non-contrast CT
Overview status: Source-reviewed overview
What does this software do?Authorized purpose: Brain midline-shift measurement on adult non-contrast CT
Which images or clinical context are in scope?Modality: CT/CTA Anatomy or clinical context: Brain Input: DICOM non-contrast head CT in adults
Who uses it?Intended users: Medical professionals using midline shift as a clinical metric
What does the software produce?Output: Color overlay showing expected and indicated midline at the Foramen of Monro; quantitative JSON measurement in millimeters; reports and DICOM Secondary Capture series
What is its most important limitation?Key limitation: Results are not intended for standalone clinical decisions and do not replace clinical assessment of NCCT cases
Clinical takeaway
Clinical role: Brain midline-shift measurement on adult non-contrast CT
Evidence takeaway
Evidence from the reviewed source record: Standalone validation used 153 NCCT cases from 13 sites (11 US, 2 outside US), ages 26-93, compared with three-expert reference. FDA-reported Rapid MAE was 0.7 mm versus expert average pairwise MAE 1.0 mm. Test cases were separate from development data.
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
Brain midline-shift measurement on adult non-contrast CT
Color overlay showing expected and indicated midline at the Foramen of Monro; quantitative JSON measurement in millimeters; reports and DICOM Secondary Capture series
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
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
Standalone validation used 153 NCCT cases from 13 sites (11 US, 2 outside US), ages 26-93, compared with three-expert reference. FDA-reported Rapid MAE was 0.7 mm versus expert average pairwise MAE 1.0 mm. Test cases were separate from development data.
Population153 adult artifact-free CT cases with intracranial pathologies from 13 centers
Scopeproduct family
Tested versionRapid MLS; exact version not established in reviewed abstract
Samplen=153
Sites13
IndependenceIndependence not established
PMID:42481415 · doi:10.3174/ajnr.A9540
Abstract reports 0.8 mm MAE and tendency to underestimate shifts greater than 10 mm. Not substituted for FDA 0.7 mm result. Cohort may overlap regulatory data; not counted as independent replication.
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 2026-09-06
Exact-name price/procurement search did not yield a reviewed primary-source module quote; platform bundle costs remain unestablished.
Reimbursement and coding
Research pending
Needs research
Exact FDA submission
Checked 2026-09-06
No applicable payer policy reviewed. RapidAI page references to reimbursement for other modules are not Rapid MLS coverage.
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: Standards listed in a regulatory summary do not establish a current scoped security certification or installation-specific controls.
Verify training: End-user onboarding, large-shift review guidance and local competency requirements remain unestablished.
Verify pricing and total cost: Exact-name price/procurement search did not yield a reviewed primary-source module quote; platform bundle costs remain unestablished.
Verify reimbursement and coding relevance: No applicable payer policy reviewed. RapidAI page references to reimbursement for other modules are not Rapid MLS coverage.
Verify local validation and lifecycle monitoring: Site acceptance could audit measurement outliers and routing failures; no specific monitoring feature or SLA established.
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
2026-09-06Last searched
19Fields reviewed
11Source classes checked
1Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
Stored PubMed candidate and live abstract reviewed; retained as family evidence with uncertain version and possible regulatory cohort overlap. Stored trial array empty. The current discovery snapshot contains 1 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 product page, literature index, peer reviewed publication, trial registry, recall database, 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 history9 sources - 3 history items
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