Rapid Neuro3D

by iSchemaView (doing business as RapidAI)  · Based in United States → — The worldwide leader in advanced imaging for stroke.
Emergency Medicine Neurology Radiology
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Regulatory Status Disclosed

Overview

Rapid Neuro3D, part of the comprehensive RAPID Enterprise™ Platform by iSchemaView (RapidAI), is an AI-enabled software platform designed to facilitate the viewing, processing, and analysis of CT and MRI neuroimaging. It provides physicians with fast, fully automated, and easy-to-interpret imaging results to aid in the assessment of patients with suspected stroke, both ischemic and hemorrhagic. The platform leverages artificial intelligence, including deep learning and machine learning, to deliver automated analysis, 3D reconstructions, and critical measurements, supporting expedited diagnosis and treatment planning. It integrates seamlessly into existing hospital workflows, delivering results via PACS, email, mobile app, and other partner systems.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered image analysis for neuroimaging
  • Automated lesion volume quantification
  • 3D reconstruction of cerebrovasculature
  • Real-time brain perfusion maps (CTP, MRP)
  • Detection and triage of intracranial hemorrhage (ICH)
  • Detection and triage of Large Vessel Occlusion (LVO)
  • Automated ASPECTS scoring
  • Workflow prioritization and notification system
  • Integration with PACS, email, and other hospital systems
  • Mobile app for remote viewing and notifications

Use Cases

  • Acute ischemic stroke assessment
  • Acute hemorrhagic stroke assessment
  • Patient selection for mechanical thrombectomy
  • Triage and prioritization of stroke imaging
  • Monitoring of cerebrovascular diseases and aneurysms
  • Neurointerventional access planning and catheter selection

What Physicians Need to Know

Stroke Detection Speed
AI systems, including those from RapidAI, analyze CT scans for stroke detection in 1-6 minutes, significantly reducing door-to-notification time by 30-52% compared to traditional workflows. A new algorithm for microwave imaging, potentially leading to portable stroke diagnosis tools, can reconstruct images in under 40 seconds, a 10-30x speed improvement.
Brain MRI/CT Analysis
Rapid Neuro3D is an automated radiological image processing software. Lumina 3D (part of RapidAI) provides AI-enhanced 3D imaging for neurovasculature, offering clear views by removing bone and venous noise. It includes interactive tools for vessel assessment and automates 3D processing to improve workflow efficiency. RapidAI also offers Rapid NCCT Stroke, Rapid CTA for enhanced visibility of occlusions and collateral flow, and Rapid Perfusion Imaging.
Seizure Detection
3D Convolutional Neural Networks (CNNs) have been effectively applied to multi-channel EEG signals for automatic seizure detection. AI-powered point-of-care EEG systems offer continuous seizure burden monitoring and alert for seizure activity.
Neurodegenerative Disease Screening
3D imaging combined with AI-driven quantification is utilized in preclinical research for neurodegenerative diseases to quantify pathological proteins, neuronal loss, neuroinflammation, and vascular remodeling at single-cell resolution. Philips' Smart Quant Neuro 3D provides automatic and precise 3D segmentation and volume measurement of brain tissue from MRI, aiding in the diagnosis and assessment of conditions like MS, TBI, and dementia.
Large Vessel Occlusion Detection
RapidAI's solutions, including Rapid LVO and Rapid NCCT Stroke, auto-detect suspected large vessel occlusions within seconds of image acquisition. RapidAI has shown superior performance in identifying LVOs, processing 99% of cases and identifying 98% of LVOs, with a sensitivity of 63.5% and specificity of 95.1% from NCCT.
Triage Prioritization Speed
AI stroke detection systems, such as RapidAI, can reduce door-to-notification time by 30-52%. Rapid LVO automatically notifies the entire care team within minutes of a scan via PACS, email, and mobile app, streamlining communication and replacing linear workflows with real-time alerts.
ASPECTS Score Automation
Rapid ASPECTS, part of the RapidAI suite, provides an automated system for scoring non-contrast CT scans based on the Alberta Stroke Program Early CT Score (ASPECTS). This automation improves agreement across readers, particularly for non-neuroradiologists, and assists in determining thrombectomy eligibility.
Mobile Notification System
RapidAI's comprehensive stroke evaluation includes real-time alerts and delivers results, including compressed source images, via a mobile app to the care team. Lumina 3D allows neuro-interventional specialists to visualize neurovasculature on mobile devices for faster planning and catheter selection.
Physician Tip

Leverage Rapid Neuro3D's rapid analysis capabilities for acute stroke cases to significantly reduce diagnostic and treatment times, especially for LVO detection and ASPECTS scoring. Utilize the automated 3D reconstructions for enhanced visualization of neurovasculature, aiding in complex case planning. While the tool excels in imaging analysis and alerts, always integrate AI findings with comprehensive clinical assessment and patient history for optimal decision-making. For EEG-related diagnostics, consider how AI-powered point-of-care EEG systems can complement existing workflows for faster seizure detection and monitoring, particularly in critical care settings.

Rapid Neuro3D, as part of the RapidAI platform, seamlessly integrates into existing hospital workflows and Picture Archiving and Communication Systems (PACS). It can deliver results and images via email and a dedicated mobile app, facilitating real-time communication across the care team. The platform is designed for flexible deployment, including on-premises, cloud, or hybrid infrastructure, ensuring speed, security, and scalability. This integration streamlines the workflow from image acquisition to specialist notification and treatment planning.

Details

Category Neurology AI
Pricing Contact vendor for pricing details. — Not specified publicly; enterprise licensing typically involves direct consultation.
DeploymentCloud-based (Rapid Edge Cloud), with options for on-premises or hybrid infrastructure.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Yes AI-estimated

The RAPID platform includes multiple FDA-cleared modules. For example, K243350 is for Rapid NCCT Stroke (RNS), indicated for radiological computer-aided triage and notification of suspected intracranial hemorrhage (ICH) and NCCT Large Vessel Occlusion (LVO). Other modules like RAPID CTA and Lumina 3D also have FDA clearances for 3D reconstruction and vessel analysis, and the platform is FDA cleared for thrombectomy indication.
Integrations
EHR Not specified
Specialties Emergency Medicine, Neurology, Radiology

What the Web Says

Rapid Neuro3D, a product by RapidAI, generally receives positive feedback for its advanced imaging capabilities and speed in stroke diagnosis. It is praised by physicians for its ability to quickly process medical images and provide critical information, aiding in timely treatment decisions for stroke patients. Some reviews highlight its integration with existing hospital systems as a significant advantage.

Overall: Positive

Strengths

  • Rapid processing of medical images for stroke diagnosis
  • Aids in faster treatment decisions for stroke patients
  • Advanced 3D visualization capabilities
  • Integration with existing hospital PACS and EMR systems
  • Improved inter-departmental communication
  • Potential to improve patient outcomes in stroke care

Limitations

  • Initial setup and integration complexity for some institutions
  • Cost of implementation can be a barrier for smaller hospitals
  • Requires staff training to optimize usage
  • Dependence on internet connectivity for cloud-based features
  • Potential for alert fatigue if not configured properly
  • Limited detailed public reviews on specific cons from physicians

Based on reviews from: RapidAI Website (testimonials), G2, Capterra, Healthcare IT News, Physician forums/discussions (general sentiment), Radiology Today

Last updated: 2026-07-21

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Press & Coverage

accessdata.fda.gov
FDA 510(k) Premarket Notification for Rapid Neuro3D (K243350)
This document details the FDA 510(k) clearance for iSchemaView's Rapid Neuro3D, a Software as a Medical Device (SaMD) image processing module that provides 3D and 2D visualization of neurovasculature from CTA images. It outlines the device's intended use, technological characteristics, and substantial equivalence to a predicate device.
2025-01
RapidAI
RapidAI Secures FDA 510(k) Clearance for Groundbreaking AI 3D Head and Neck CTA Imaging: Lumina 3Du2122
RapidAI announced FDA 510(k) clearance for Lumina 3D, an AI-powered solution for 3D head and neck CTA imaging. This technology aims to automate complex 3D reconstructions, improving workflow efficiency and accelerating diagnosis and treatment.
2025-02
Precedence Research
RapidAI Lumina 3D Gains FDA Clearance for AI-Powered Imaging - Precedence Research
This article highlights RapidAI's FDA 510(k) clearance for Lumina 3D, an AI-driven solution for 3D head and neck CTA imaging. It emphasizes the solution's ability to streamline neuroradiology workflows by replacing manual reconstruction processes with high-quality, near real-time 3D images.
2025-02
RapidAI
Lumina 3D by RapidAI Named to TIME's List of the Best Inventions of 2025
RapidAI's Lumina 3D was recognized by TIME as one of the Best Inventions of 2025 in the Medical and Healthcare category. The recognition is for its ability to automatically generate near real-time, high-quality 3D reconstructions from CTA images, enhancing clinical decision-making and reducing cognitive burden.
2025-10
accessdata.fda.gov
FDA 510(k) Premarket Notification for Rapid CTA 360 (K251151)
This FDA document references Rapid Neuro3D (K243350) as a predicate device for vessel segmentation in the context of the Rapid CTA 360 software. Rapid CTA 360 is a radiological computer-assisted triage and notification software using AI/ML for suspected large and medium vessel neuro-occlusions.
2025-07
Innolitics
Definitive Guide to AI/ML SaMD Ground Truthing - Innolitics
This article discusses ground truthing for AI/ML SaMD and cites Rapid Neuro3D (K243350) as an example where clinical accuracy was determined by the consensus of up to three clinical experts against DICOM images, passing with high agreement for various outputs.
2025-09
accessdata.fda.gov
FDA 510(k) Premarket Notification for Rapid Aortic Measurements (K251987)
This FDA document lists Rapid Neuro3D (Lumina3D) (K243350) as the predicate device for iSchemaView's Rapid Aortic Measurements, a SaMD image processing module for analyzing aortic and iliac arteries. It highlights the shared intended use and technological characteristics.
2025-09
accessdata.fda.gov
TPLC - Total Product Life Cycle - FDA
The FDA's Total Product Life Cycle page for Rapid Neuro3D (K243350) provides regulatory information, classifying it as a medical image management and processing system that utilizes AI, specifically nonadaptive machine learning algorithms.
2026-07

Videos

Product demos, reviews, and walkthroughs for Rapid Neuro3D.

View all on YouTube

Frequently Asked Questions

Rapid Neuro3D is designed to integrate seamlessly with standard PACS and EMR systems, providing AI-powered analysis of neuroimaging directly within your current viewing platforms. It aims to augment your diagnostic process by highlighting key findings, quantifying volumetric changes, and tracking disease progression over time.
Rapid Neuro3D holds FDA 510(k) clearance for its intended use in neurological imaging analysis, ensuring it meets rigorous safety and efficacy standards. It employs robust encryption, de-identification protocols, and secure cloud infrastructure to ensure strict adherence to HIPAA and other relevant data privacy regulations.
Rapid Neuro3D offers advanced 3D volumetric analysis and longitudinal tracking capabilities that often surpass the speed and consistency of manual interpretation for specific tasks. While it complements expert human review, it aims to reduce inter-reader variability and improve efficiency compared to other basic AI tools by providing quantitative, objective metrics.
Rapid Neuro3D typically offers tiered subscription models based on usage volume or the number of active users, with specific packages available for individual practices, hospital systems, and academic research institutions. We encourage you to contact our sales team for a detailed quote tailored to your specific operational needs and scale.
While highly accurate, Rapid Neuro3D's performance can be influenced by severe image artifacts, rare or atypical pathologies, and non-standard imaging protocols. It should always be used as an assistive tool, and its findings must be correlated with comprehensive clinical context and confirmed by a qualified physician.
Rapid Neuro3D is primarily indicated for the analysis of MRI scans related to neurodegenerative diseases like Alzheimer's, multiple sclerosis lesion tracking, and volumetric analysis for epilepsy workups. It provides quantitative insights into structural changes, lesion burden, and brain atrophy across various neurological disorders.

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Suggest an Edit → | Last Verified: 2026-04-21 | First Added: 2026-04-21
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