Ceevra Reveal 3+

by Ceevra  · Based in United States → — Advanced AI 3D Surgical Visualization for Enhanced Patient Outcomes
Cardiothoracic Surgery General Surgery Neurosurgery

Subscription model with tiers based on anticipated volume and specialties.
Regulatory Status Disclosed

Overview

Ceevra Reveal 3+ is a software medical device that processes CT and MRI scans to generate detailed three-dimensional images. It employs machine learning algorithms to assist clinicians in segmenting and visualizing normal anatomy, supporting preoperative surgical planning and intraoperative display. The software is accessible via mobile devices, desktop computers, external displays, and virtual reality headsets, offering interactive features such as rotation, zooming, panning, selective visibility of anatomical structures, and the ability to view measurements of or between anatomical structures.

The platform is designed to be easy to implement and use, requiring minimal effort from hospital personnel beyond uploading source CT and MR imaging to Ceevra’s HIPAA-compliant cloud. Ceevra’s 3D models are tailored for specific surgery types, helping surgeons understand complex anatomical relationships and potential invasion. This technology aims to improve patient outcomes, enhance patient understanding, and reduce anxiety during surgical planning.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-driven 3D surgical imaging
  • Automated generation of 3D models from CT and MRI scans
  • Interactive visualization of patient anatomy (rotation, zooming, panning, selective show/hide)
  • Support for various surgical specialties
  • Accessible on multiple devices (phones, tablets, laptops, surgical robotic displays, VR headsets)
  • No input required from hospital personnel for model generation (beyond uploading scans)
  • Tailored anatomical structures for specific surgeries
  • Improved surgical planning and patient counseling
  • Margin simulator tool (for thoracic surgery)
  • Viewing measurements of or between anatomical structures

Use Cases

  • Preoperative surgical planning
  • Intraoperative display and visualization
  • Patient counseling and education
  • Improving patient outcomes in complex surgeries
  • Assisting in clinical decision-making
  • Understanding complex anatomical relationships and potential invasion

What Physicians Need to Know

DICOM Support & Standards
Ceevra Reveal 3+ processes multi-dimensional digital images from CT and MR imaging devices, supporting DICOM, HL7, and FHIR data standards.
PACS Integration Method
Integration involves hospital IT staff installing Ceevra software on end-user computers and connecting it to the hospital PACS. Patient CT/MRI scans are then uploaded to Ceevra's HIPAA-compliant cloud.
Reading Room Workflow Impact
The software is designed for easy implementation, requiring minimal effort from hospital personnel beyond uploading imaging data. Ceevra generates 3D models within two business days, which surgeons can view interactively on various devices (computers, phones, tablets, surgical robotic displays). This facilitates preoperative planning, patient counseling, and intraoperative display, potentially leading to improved surgical outcomes.
AI Model Architecture (deep learning approach)
Ceevra Reveal 3+ utilizes AI-driven software, employing machine learning and computer vision algorithms for automated segmentation and visualization of normal anatomy from CT and MRI scans. It includes four machine learning models, validated with diverse patient and scanner datasets. The ML algorithms are specifically for adult patients (22 and over).
Processing Speed (per study)
3D models are typically generated within two business days.
FDA Clearance Pathway (510k/De Novo)
Ceevra Reveal 3+ is FDA-cleared as a Class II medical device, having received 510(k) clearance (K222676 for Ceevra Reveal 3 and K233568 for Ceevra Reveal 3+). The 510(k) clearance for Ceevra Reveal 3 was notable as its first version to incorporate machine learning algorithms.
Supported Modalities (CT/MRI/X-ray/US)
The tool supports Computed Tomography (CT) and Magnetic Resonance Imaging (MRI) scans.
Sensitivity & Specificity Data
The device has been validated for high performance in segmenting anatomical structures. Measurement features (volumes, diameters, distances) have been verified to be accurate within a mean difference of +/- 10%. Randomized clinical trials have demonstrated improved patient outcomes, such as reduced operative time, estimated blood loss, and hospital stay for robotic partial nephrectomy, and enhanced cancer control and erectile function for robotic prostatectomy.
Physician Tip

Ceevra Reveal 3+ offers a powerful tool for enhancing preoperative planning and intraoperative visualization through interactive 3D models derived from CT and MRI scans. Physicians can leverage its AI-driven segmentation to gain a clearer understanding of complex anatomy, tailor surgical approaches, and improve patient counseling by visually explaining diagnoses and proposed procedures. The ability to view models on various devices, including surgical robotic displays, supports flexible integration into existing workflows. Consider its potential to reduce operative times, blood loss, and hospital stays, as demonstrated in clinical trials for specific procedures. Note that the machine learning algorithms are validated for adult patients (22 and over).

Ceevra Reveal 3+ integrates with hospital PACS systems for image acquisition and supports DICOM, HL7, and FHIR standards for data exchange. The software is cloud-based and HIPAA-compliant, with 3D models accessible via mobile devices, desktop computers, external displays, and virtual reality headsets. Implementation requires hospital IT staff to install the software and connect it to PACS, followed by a simple workflow for uploading patient imaging to Ceevra's cloud for model generation.

Details

Category Radiology & Imaging AI, Surgical AI
Pricing Subscription model with tiers based on anticipated volume and specialties. — Annual software subscription; tiers based on anticipated volume; no one-time or variable fees.
DeploymentSaaS (Cloud-based)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Ceevra Reveal 3+ received FDA 510(k) clearance (K243933) on March 4, 2025. Earlier versions, Ceevra Reveal 3 (K222676) and Ceevra Reveal 2.0 (K173274), also received FDA clearances for similar indications.

Integrations
EHR Not specified
Specialties Cardiothoracic Surgery, General Surgery, Neurosurgery

What the Web Says

Ceevra Reveal 3+ is an FDA-cleared, AI-powered software that transforms CT and MRI scans into interactive 3D models for surgical planning and intraoperative visualization. It aims to improve surgical outcomes by providing surgeons with a detailed understanding of patient anatomy and assisting in clinical decision-making. The software is accessible on various devices, including mobile, desktop, and VR headsets.

Overall: Positive

Strengths

  • Provides highly detailed, interactive 3D models from standard CT and MRI scans.
  • Aids in more precise preoperative planning, potentially reducing operative time, blood loss, and hospital stays.
  • Enhances patient understanding and reduces anxiety by allowing them to visualize their anatomy and proposed procedures.
  • Utilizes AI and machine learning for automated segmentation and visualization of anatomy.
  • Accessible on multiple platforms, including mobile devices, desktops, and VR headsets.
  • FDA-cleared for various surgical specialties, including urologic, thoracic, gynecologic, hepatobiliary, and general surgery.

Limitations

  • Machine learning algorithms are currently only for adult patients (22 and over).
  • Pricing is subscription-based and requires contacting the vendor, with costs dependent on the estimated number of scans per year.
  • Some general perceptions of similar technologies mention limitations due to unknown costs and time for acquisition.

Based on reviews from: HealthAidb, X-ray Interpreter, accessdata.fda.gov, PMC, Innolitics, FirstWord HealthTech, Saint John's Cancer Institute Blog, The AdventHealth Blog, The Bleeding Edge of Digital Health

Last updated: 2026-07-17

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Press & Coverage

RadAI Slice
Ceevra Reveal 3+ | FDA Radiology AI Device - X-ray Interpreter
Ceevra Reveal 3+ is an FDA-approved software as a medical device that transforms CT and MR images into interactive 3D visualizations for preoperative and intraoperative use, employing machine learning and computer vision algorithms for semi-automated segmentations of normal anatomy. It received FDA approval on March 4, 2025.
2025-03
PubMed (Cureus)
A Comprehensive Review of Food and Drug Administration (FDA)-Cleared Virtual Reality Technologies in Radiology - PubMed
This review highlights Ceevra Reveal 3+ as one of seven FDA-cleared VR systems with direct applications in radiology, enabling users to visualize and manipulate radiological data in immersive 3D space for enhanced diagnostic precision and procedural planning. The article, published in June 2025, assesses the clinical functions and future potential of these technologies.
2025-06
accessdata.fda.gov
Ceevra, Inc. Ken Koster Cto 149 New Montgomery St. 4th Floor San Francisco, CA 94105 Re: K233568 Trade/Device Name - accessdata.fda.gov
This FDA document from December 2023 details the 510(k) summary for Ceevra Reveal 3+, indicating its substantial equivalence to the originally cleared Reveal 3 device (K222676) and its intended use for preoperative surgical planning and intraoperative display for adult patients. The document specifies that the device uses machine learning algorithms for preliminary segmentations of normal anatomy.
2023-12
FDA
Augmented Reality and Virtual Reality in Medical Devices - FDA
Ceevra Reveal 3+ is listed among FDA-cleared Augmented Reality and Virtual Reality medical devices, categorized under Radiology with product code QIH and a clearance date of November 2, 2023. This resource provides transparency for healthcare providers and patients regarding AR/VR medical technologies.
2023-11
AJR Online
Opportunistic Screening on Chest CT, From the AJR Special Series on Screening - AJR Online
This July 2025 review article mentions Ceevra Reveal 3+ as an FDA-approved AI tool for segmentation and preoperative planning based on CT scans, with a clearance date of December 5, 2023. It highlights the role of such tools in opportunistic screening and leveraging imaging biomarkers from chest CT scans.
2025-07
HealthAidb
Ceevra Reveal 3+ - HealthAidb u2014 Software
Ceevra Reveal 3+ is an FDA-cleared and CE Marked software that transforms CT and MRI scans into interactive 3D models for preoperative planning and intraoperative visualization across various surgical specialties. The software, released in 2018, utilizes AI-driven 3D surgical imaging and is accessible on multiple devices.
2025-10
PMC (Journal of Thoracic Disease)
3-dimensional reconstruction and mixed reality in thoracic surgery: a narrative review and user guide - PMC
This narrative review from December 2023 mentions Ceevra Reveal 3+ as an FDA-cleared, AI-assisted VR platform for preoperative planning in thoracic surgery, utilizing CT or MRI scans to create 3D reconstruction models. It highlights the growing use of such technologies in surgical planning.
2023-12
ResearchGate
A Comprehensive Review of Food and Drug Administration (FDA)-Cleared Virtual Reality Technologies in Radiology - ResearchGate
Published in June 2026, this comprehensive review identifies Ceevra Reveal 3+ as one of seven FDA-cleared VR systems in radiology, emphasizing its role in transforming DICOM data into high-resolution anatomical models for collaborative exploration in a VR environment. The article discusses how these platforms enhance diagnostic precision and procedural planning.
2026-06

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Frequently Asked Questions

Ceevra Reveal 3+ transforms CT and MRI scans into interactive 3D models, aiding clinicians in preoperative planning and intraoperative visualization. It supports various surgical specialties, including thoracic, urologic, gynecologic, hepatobiliary, and general surgery, and can be accessed on mobile devices, desktops, and VR headsets.
Ceevra Reveal 3+ is an FDA-cleared software medical device and also holds the CE Mark, indicating compliance with health, safety, and environmental protection standards for products sold within the European Economic Area. The software operates on a HIPAA-compliant cloud for data handling.
The machine learning algorithms in Ceevra Reveal 3+ are specifically validated for adult patients aged 22 and over. For patients under 22 or of unknown age, 3D images are generated without the use of AI algorithms.
While Ceevra Reveal 3+ offers AI-assisted 3D modeling, other solutions for surgical planning and visualization include ImmersiveTouch/ImmersiveAR, which uses manual segmentation, and various PACS/imaging software platforms like Medicai and UltraLinq. The choice often depends on the specific needs for AI integration, manual control, and device compatibility.
Ceevra Reveal 3+ is acquired through an annual software subscription model. The pricing is tiered and depends on the estimated number of scans a healthcare institution anticipates using per year, with no additional one-time or variable fees.
Ceevra Reveal 3+ employs machine learning algorithms to assist in segmenting and visualizing normal anatomy, and the device has been validated using diverse patient and scanner datasets, demonstrating high performance. It has also been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing, including IEC 62304.
Implementation is designed to be straightforward; hospital IT staff installs the Ceevra software on end-user computers and connects it to the hospital PACS. Patient CT/MRI images are then uploaded to Ceevra's HIPAA-compliant cloud, with Ceevra generating the 3D models.

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Ceevra Reveal 3 is an FDA-cleared software that transforms CT and MRI scans into interactive 3D models, aiding clinicians in preoperative planning and intraoperative visualization.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18

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