Authorized purpose: Rapid Neuro3D analyzes adult head-and-neck CTA DICOM from the aortic arch to the vertex, removing bone, tissue, and venous vessels to generate 3D/2D neurovascular visualizations, including MIP, volume-rendered, and CPR views of carotid and vertebral arteries for trained physicians' lesion review and planning; results are not standalone clinical decisions.
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: Rapid Neuro3D analyzes adult head-and-neck CTA DICOM from the aortic arch to the vertex, removing bone, tissue, and venous vessels to generate 3D/2D neurovascular visualizations, including MIP, volume-rendered, and CPR views of carotid and vertebral arteries for trained physicians' lesion review and planning; results are not standalone clinical decisions.
Overview status: Source-reviewed overview
What does this software do?Authorized purpose: Rapid Neuro3D analyzes adult head-and-neck CTA DICOM from the aortic arch to the vertex, removing bone, tissue, and venous vessels to generate 3D/2D neurovascular visualizations, including MIP, volume-rendered, and CPR views of carotid and vertebral arteries for trained physicians' lesion review and planning; results are not standalone clinical decisions.
Which images or clinical context are in scope?Modality: CT/CTA Anatomy or clinical context: Brain Input: Conventional adult CTA DICOM images extending from the aortic arch to the vertex of the head.
Who uses it?Intended users: Physicians and trained clinical professionals evaluating neurovascular CTA; the physician remains responsible for clinical assessment and decisions.
What does the software produce?Output: A DICOM series with 3D rotational maximum-intensity projections, volume renders, source-series-equivalent images with bone/tissue/vein removal, and curved planar reformations of isolated left and right internal carotid and vertebral arteries.
What is its most important limitation?Key limitation: Excessive motion or metal implants may affect output. The module excludes inadequate intracranial arterial contrast, cone-beam C-arm CT, non-axial or non-supine series, missing or improperly ordered slices, and CTA datasets outside its stated field-of-view and acquisition constraints. Results are not intended for standalone clinical decision-making.
Clinical takeaway
Clinical role: Rapid Neuro3D analyzes adult head-and-neck CTA DICOM from the aortic arch to the vertex, removing bone, tissue, and venous vessels to generate 3D/2D neurovascular visualizations, including MIP, volume-rendered, and CPR views of carotid and vertebral arteries for trained physicians' lesion review and planning; results are not standalone clinical decisions.
Evidence takeaway
Evidence from the reviewed source record: K243350 FDA evidence is manufacturer-submitted standalone regulatory validation. The quality endpoint used 120 CTA cases from 115 patients, while the accuracy endpoint used 50 CTA cases from 48 patients; their totals are kept separate. No independent paper or trial was promoted in this timeboxed review.
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
Rapid Neuro3D analyzes adult head-and-neck CTA DICOM from the aortic arch to the vertex, removing bone, tissue, and venous vessels to generate 3D/2D neurovascular visualizations, including MIP, volume-rendered, and CPR views of carotid and vertebral arteries for trained physicians' lesion review and planning; results are not standalone clinical decisions.
Automated head-and-neck arterial visualization and segmentation to support physician confirmation of identified lesions, evaluation, documentation, follow-up, and treatment planning; output does not replace clinical assessment.
A DICOM series with 3D rotational maximum-intensity projections, volume renders, source-series-equivalent images with bone/tissue/vein removal, and curved planar reformations of isolated left and right internal carotid and vertebral arteries.
Excessive motion or metal implants may affect output. The module excludes inadequate intracranial arterial contrast, cone-beam C-arm CT, non-axial or non-supine series, missing or improperly ordered slices, and CTA datasets outside its stated field-of-view and acquisition constraints. Results are not intended for standalone clinical decision-making.
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Use these fields to structure a vendor demo, security review, and implementation estimate.
Integration
The Rapid Platform accepts DICOM images and returns processed DICOM images to the source imaging modality or PACS; the resulting DICOM series can be used by DICOM viewers and clinical workstations. Local routing, identifiers, viewer behavior, and failure handling require acceptance testing.
The exact Rapid Platform may be installed on-premises behind the customer firewall or in a hybrid on-premises/cloud configuration, on dedicated hardware or a virtual machine; the reviewed sources do not establish the current site-specific topology, storage, retention, availability, or service-level arrangement.
The reviewed exact packet and official family page do not establish current scoped security controls, encryption, PHI flow, retention, access control, audit, vulnerability management, or incident response for the installed K243350 release.
Training and support
Not established in reviewed sources
Reviewed sources checked
Exact FDA submission
Checked 2026-09-07
The FDA indication requires trained clinical review, but no exact-version curriculum, competency assessment, or support terms were established.
Monitoring and change control
Monitor CTA coverage and contrast eligibility, slice order and patient-position constraints, motion or metal-related failures, output review, DICOM delivery, failed or repeated analyses, reader overrides, downtime, updates, complaints, and exact-submission recalls.
FDA source
Exact FDA submission
Checked 2026-09-07
Buyer acceptance guidance derived from the exact FDA workflow and validation scope; it is not a claimed vendor monitoring service.
RapidAI's current radiologist page lists automated CTA reconstruction for the head, neck, and aortic arch, with curved planar reformats, MIPs, volume renderings, bone removal, and segmentation. This is Rapid family context and does not establish the exact K243350 release or contract configuration.
The exact FDA submission describes DICOM input and return of processed DICOM images to the source modality or PACS; confirm local routing, viewer compatibility, firewall rules, and failure recovery during qualification.
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
K243350 FDA evidence is manufacturer-submitted standalone regulatory validation. The quality endpoint used 120 CTA cases from 115 patients, while the accuracy endpoint used 50 CTA cases from 48 patients; their totals are kept separate. No independent paper or trial was promoted in this timeboxed review.
DesignStandalone performance validation comparing MIP, volume-rendered, source-series-equivalent, and CPR outputs with source DICOM and expert consensus.
Population120 CTA cases from 115 patients (104 US, 16 OUS; 65 female and 50 male; ages 27 to 90+); major CT scanner manufacturers were represented and the dataset was independent of model-training data per internal quality-control processes.
Scopeexact submission
Tested versionRapid Neuro3D configuration described in K243350
Samplen=120
IndependenceSponsor or vendor study
K243350
Manufacturer-submitted FDA evidence; this is not an independent clinical-outcome study.
DesignStandalone performance validation comparing 3D visualization segmentation with ground truth or predicate reference and CPR centerlines with ground truth.
Population50 CTA cases from 48 patients (43 US, 7 OUS; 24 female and 24 male; ages 27 to 90+), assessed for extracranial and intracranial regions and CPR centerline accuracy.
Scopeexact submission
Tested versionRapid Neuro3D configuration described in K243350
Samplen=50
IndependenceSponsor or vendor study
K243350
Manufacturer-submitted FDA evidence; the intracranial comparison used the predicate-device reference for the stated endpoint.
These are common procurement questions; unknown values remain visible until a source supports them.
Pricing and total cost
Not established in reviewed sources
Reviewed sources checked
Exact FDA submission
Checked 2026-09-07
No public list price or exact contract unit for K243350 was established in the reviewed official sources.
Reimbursement and coding
Research pending
Needs research
Exact FDA submission
Checked 2026-09-07
No payer-policy research was applied to this dossier; product-specific coverage or claim eligibility is not established.
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-submission FDA recall query returned no native recall record for K243350. This is not a comprehensive safety clearance and does not exclude family, later-version, or adverse-event information.
Verify security and privacy controls: The reviewed exact packet and official family page do not establish current scoped security controls, encryption, PHI flow, retention, access control, audit, vulnerability management, or incident response for the installed K243350 release.
Verify training: The FDA indication requires trained clinical review, but no exact-version curriculum, competency assessment, or support terms were established.
Verify pricing and total cost: No public list price or exact contract unit for K243350 was established in the reviewed official sources.
Verify reimbursement and coding relevance: No payer-policy research was applied to this dossier; product-specific coverage or claim eligibility is not established.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-07Last searched
24Fields reviewed
11Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
The stored PubMed and ClinicalTrials.gov candidate arrays were screened and were empty. No paper or trial was promoted; empty stored arrays do not establish that no external literature or trials exist. 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, vendor product page, fda device recall, literature index, trial registry, stored candidate metadata, 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 history8 sources - 3 history items
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