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
Brain midline-shift measurement on adult non-contrast CT
FDA source Exact FDA submission Checked 2026-09-05
Color overlay showing expected and indicated midline at the Foramen of Monro; quantitative JSON measurement in millimeters; reports and DICOM Secondary Capture series
FDA source Exact FDA submission Checked 2026-09-06
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
K243378
FDA source Exact FDA submission Checked 2026-08-31
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
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.
FDA source Exact FDA submission Checked 2026-09-06
Automated midline-shift measurement evaluation reported in AJNR
Retrospective multicenter expert-reference comparison · 153 adult artifact-free CT cases with intracranial pathologies from 13 centers
product family · Tested version: Rapid MLS; exact version not established in reviewed abstract · n=153 · 13 sites · Independence 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
1Reviewed PubMed leads
0Reviewed 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
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