Rapid CTA 360

by RapidAI (formerly iSchemaView)  · Based in United States →AI beyond the algorithm™: The gold standard in stroke care.
Emergency Medicine Neurology Radiology

Contact vendor for pricing
Regulatory Status Disclosed

Overview

Rapid CTA 360, developed by RapidAI (formerly iSchemaView), is an advanced AI-powered imaging solution designed to revolutionize stroke diagnosis and treatment planning. It provides fully automated, high-quality 3D reconstructions of head, neck, and aortic arch CT angiography (CTA) scans within minutes. The tool enhances visibility of distal occlusions and collateral flow through color-coded overlays that identify brain regions with reduced blood vessel density. Physicians can view and analyze these 3D reconstructions from multiple angles, facilitating precise stroke diagnosis and treatment decisions. Rapid CTA 360 is part of the broader RapidAI platform, which offers a comprehensive suite of AI tools for acute stroke care, aiming to expedite time to treatment, improve workflow efficiencies, and ultimately enhance patient outcomes.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automated 3D CTA reconstructions of head, neck, and aortic arch
  • Color-coded overlays for identifying brain regions with reduced blood vessel density
  • Multi-angle 3D reconstructions for precise visualization of vasculature
  • Automated assessment of collateral vessels
  • Mobile device access for remote viewing and analysis
  • Integration with PACS and reporting systems
  • AI-driven worklist prioritization (as part of RapidAI platform)
  • Reduced manual steps and cognitive burden for radiologists
  • Facilitates clinical decision-making and patient triage
  • Supports collaboration between community hospitals and specialists

Use Cases

  • Acute ischemic stroke diagnosis and treatment planning
  • Identification of large vessel occlusions (LVO)
  • Patient selection for mechanical thrombectomy
  • Expediting time between CT and CTA scans
  • Remote image review and consultation
  • Workflow triage and prioritization of medical images

What Physicians Need to Know

Evidence Base
Rapid CTA is part of the RapidAI neuroimaging platform, FDA-cleared since May 2018, designed to aid clinical decision-making for cerebrovascular diseases like stroke. Its underlying AI technology contributed to changes in American Heart Association (AHA) and American Stroke Association (ASA) stroke guidelines, extending the treatment window for mechanical thrombectomy. The platform leverages insights from over 5 million scans across 2,000+ hospitals in 100+ countries. Peer-reviewed literature supports its use, including studies on large vessel occlusion detection and workflow outcomes.
Clinical Validation Studies
Rapid CTA has received FDA clearance. A 2021 study demonstrated a high positive predictive value (87%) for large vessel occlusion (LVO) and 80% sensitivity with a 45% relative vessel density threshold. This study also reported a significant reduction in time to treatment (CTA to groin puncture time) after Rapid CTA deployment (93 min vs. 68 min, p<0.05). An independent assessment of similar AI software for stroke CTA showed diagnostic accuracy ranging from 72-76% compared to expert interpretation. An interim audit comparing RAPID software with standard radiology interpretation found an overall diagnostic performance of sensitivity 75%, specificity 41%, positive predictive value 23%, and diagnostic accuracy 48%, emphasizing its role as a decision support tool to be used in conjunction with radiologist review.
Differential Diagnosis Support
Rapid CTA provides automated analysis of CTA images, identifying brain regions with reduced blood vessel density, quantifying impacted vasculature, and assessing collateral vessels with color-coded overlays and 3D reconstructions. This directly supports the differential diagnosis of stroke by quickly identifying large vessel occlusions (LVOs) in key arteries (ICA, MCA, ACA, Basilar, PCA) and informing treatment decisions.
Guideline Update Frequency
RapidAI's platform has been instrumental in influencing major stroke guidelines (AHA/ASA) by providing evidence for extended treatment windows. The company continuously evolves its platform, adding new products and features, indicating an ongoing process of incorporating new clinical understanding and aligning with updated guidelines.
Clinical Workflow Integration
Rapid CTA offers fast, fully-automated processing, delivering results in 3 minutes or less. Image maps are immediately accessible on desktop or mobile devices, facilitating remote viewing and telehealth applications. The Rapid Workflow for Stroke solution provides notifications and access to critical images and results, streamlining communication and coordination for stroke care teams. It integrates with Electronic Medical Record (EMR) systems to provide a single source of truth.
Physician Tip

Rapid CTA is a powerful AI-driven tool for rapid assessment of cerebrovascular disease, particularly in acute stroke. Utilize its automated analysis for quick identification of large vessel occlusions, assessment of collateral flow, and 3D vascular reconstructions to expedite diagnosis and treatment decisions. Always integrate the AI findings with your comprehensive clinical evaluation and source image interpretation, as the software is a decision support tool, not a replacement for expert review. Leverage its mobile accessibility for timely decision-making and inter-hospital transfer coordination.

RapidAI's platform, including Rapid CTA, is designed for seamless integration into existing clinical workflows and IT infrastructure. It utilizes RESTful APIs and supports JSON data format for data exchange, with OAuth 2.0 for secure authentication. This allows for integration with PACS, EMR systems, and mobile devices, ensuring results are delivered quickly and efficiently to relevant care team members.

Details

Category Neurology AI, Radiology & Imaging AI
Pricing Contact vendor for pricing N/A
DeploymentOn-premise, cloud, or hybrid infrastructure (Rapid Edge Cloud)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Yes AI-estimated

Rapid CTA 360 (K251151) is FDA-cleared as Radiological Computer-Assisted Triage And Notification Software. It provides 3D imaging solutions for Computed Tomography Angiography, offering clear maps with colored overlays to identify brain regions with reduced blood vessel density and 3D reconstructions of vasculature for stroke diagnosis and treatment planning.

Integrations
EHR Not specified
Specialties Emergency Medicine, Neurology, Radiology

What the Web Says

Rapid CTA 360, part of the RapidAI platform, is an AI-powered software designed to assist physicians in the rapid detection and assessment of stroke by analyzing CT angiography images. It aims to improve the efficiency of the diagnostic process and facilitate quicker treatment decisions for stroke patients. The software provides automated interpretation of CTA maps, including color-coded overlays to identify occlusions and 3D reconstructions for enhanced visualization. While it has shown potential in reducing time-to-intervention and improving diagnostic accuracy when used in conjunction with clinician interpretation, some studies highlight limitations in its standalone accuracy and the need for more robust evidence on patient outcomes and cost-effectiveness.

Overall: Mixed

Strengths

  • Potential to improve acute stroke care by creating efficiencies in the diagnostic process.
  • Provides fast, fully-automated, and easy-to-interpret imaging.
  • Offers remote viewing capabilities for physicians on various devices.
  • Helps identify the area of occlusion and quantify impacted vasculature with color-coded overlays and 3D reconstructions.
  • Can reduce CTA-to-groin puncture time, potentially improving patient outcomes.
  • Facilitates communication and collaboration among stroke teams.

Limitations

  • Impact on many important patient outcomes (e.g., harms, mortality, quality of life) is uncertain due to limited evidence.
  • Cost-effectiveness for stroke detection is currently unknown.
  • Low-certainty evidence for its effects on functional status and response to therapy.
  • Standalone diagnostic accuracy can be limited, with instances of false positives.
  • Ethical considerations regarding patient autonomy, privacy, transparency, access, and algorithmic bias.
  • Some users have reported glitches with the mobile app, including issues with notifications and logging in.

Based on reviews from: NCBI Bookshelf, Indeed.com, Canadian Journal of Health Technologies, NeuroNews International, Apple App Store, Reddit, Xtalks, RapidAI, G2, Capterra

Last updated: 2026-07-21

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Press & Coverage

accessdata.fda.gov
510(k) Premarket Notification K251151 - Rapid CTA 360
The FDA granted 510(k) clearance to iSchemaView for Rapid CTA 360 on July 16, 2025. This radiological computer-aided triage and notification software uses AI/ML to analyze adult head CTA images for suspected large and medium vessel neuro-occlusions.
2025-07
Innolitics
2025 Year in Review: Cardiology AI/ML SaMD 510(k) Clearances
This article provides a comprehensive analysis of 2025 cardiology AI/ML clearances, including the Rapid CTA 360 by iSchemaView, which received its 510(k) clearance on July 16, 2025.
2026-01
X-ray Interpreter
Rapid CTA 360 | FDA Radiology AI Device
Rapid CTA 360, developed by iSchemaView Inc., is listed as a 2025 510K FDA-cleared device. It is designed to detect large-vessel occlusion, perfusion deficits, and aortic findings.
2025-08
Osler, Hoskin & Harcourt LLP
Governing AI in Ontario hospitals: oversight, opportunity and risk
This article discusses the governance of AI in Ontario hospitals, mentioning Rapid CTA 360 (K251151) as a device that detects large-vessel occlusion, perfusion deficits, and aortic findings.
2026-07
Rad AI Slice
AI Models Diagnose Dementia Across Real-World Brain Images | Rad AI Slice
Rapid CTA 360 (K251151) is noted for triaging and notifying critical findings on CT angiography for urgent vascular care.
2025-07
Innolitics
Definitive Guide to AI/ML SaMD Ground Truthing
This guide on AI/ML SaMD ground truthing references Rapid CTA 360 (K251151) and its final performance validation, which included 403 CTA cases with ground truth established by three experts.
2025-09
Innolitics
Foundation Models in AI SaMD: A Snapshot
This article discusses how regulatory documentation for devices like Rapid CTA 360 often uses generic machine learning terms to describe their technology, despite marketing materials highlighting foundation models.
2026-05

Videos

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Frequently Asked Questions

Rapid CTA 360, encompassing modules like Rapid CTA and Lumina 3D by RapidAI, primarily addresses acute stroke care by facilitating the rapid detection of large vessel occlusions (LVOs) and intracranial hemorrhages (ICH) through automated CT angiography analysis and 3D reconstructions. It integrates into existing workflows by providing fast, automated image processing and delivering results to clinicians via PACS, email, and mobile devices, enabling quicker diagnostic and treatment decisions.
Rapid CTA 360 significantly enhances speed and efficiency by providing automated analysis and 3D reconstructions of CTA scans within minutes, which traditionally take hours with manual methods. This rapid processing, coupled with real-time alerts and mobile access to critical imaging, helps expedite triage, treatment, and transfer decisions for stroke patients.
Rapid CTA, a core component of Rapid CTA 360, has received FDA 510(k) clearance as a Class II medical device. While it is a cleared tool to aid in clinical decision-making, it is intended to complement, rather than replace, direct clinician interpretation of CT imaging.
Key alternatives in AI-powered neurovascular imaging analysis include platforms like Aidoc, Viz.ai, and Brainomix 360 Stroke. RapidAI differentiates itself through its comprehensive enterprise platform offering a broad suite of clinically validated modules for various stroke and vascular conditions, along with advanced 3D reconstruction capabilities and seamless workflow integration.
It is crucial to understand that Rapid CTA 360 is a decision support tool and should not be used in isolation, as it complements rather than replaces clinician interpretation. Potential pitfalls include the possibility of false positives due to imaging artifacts or software limitations, and some studies indicate a need for more evidence on its direct impact on patient-important outcomes.
Rapid CTA 360 is typically offered under an annual subscription model, with pricing varying based on factors like region, hospital type, and the specific modules purchased. The cost-benefit analysis often highlights a strong return on investment through reduced post-processing times, increased treatment revenue by identifying more eligible patients, and cost savings from avoiding unnecessary patient transfers.

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