Ceevra Reveal 3

by Ceevra  · Based in United States → — Leading the way in AI-driven, 3D surgical imaging.
Cardiothoracic Surgery General Surgery Urology

Subscription model; contact vendor for details.
Regulatory Status Disclosed

Overview

Ceevra Reveal 3 is an FDA-cleared software as a medical device (SaMD) that processes standard CT and MRI scans to generate detailed, interactive 3D digital models of patient anatomy. Utilizing machine learning and computer vision algorithms, the platform automates the segmentation of normal anatomy, eliminating the need for manual input or effort from hospital personnel.

The tool is designed for surgeons across multiple specialties, including:

  • Urological Surgery
  • Thoracic Surgery
  • Gynecological Surgery
  • General and Hepatopancreatobiliary (HPB) Surgery

In clinical workflows, Ceevra Reveal 3 serves as a diagnostic and visualization aid for both preoperative surgical planning and intraoperative reference. Surgeons can access and interact with the multi-color 3D models across various devices, including mobile phones, tablets, laptops, and compatible surgical robotic displays. The interactive models allow clinicians to rotate views, zoom in or out, and selectively hide or reveal specific anatomical structures, such as blood vessels, airways, and organs, to assist in determining the optimal surgical approach.

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 (Thoracic, Urologic, General, HPB, Gynecologic)
  • Accessible on multiple devices (phones, tablets, laptops, surgical robotic displays)
  • No input required from hospital personnel for model generation
  • Tailored anatomical structures for specific surgeries
  • Improved surgical planning and patient counseling
  • Enhanced patient understanding and reduced anxiety
  • Rapid model generation (within two business days)

Use Cases

  • Preoperative surgical planning
  • Intraoperative display and visualization
  • Patient counseling and education
  • Identifying anatomical variants pre-operatively
  • Improving patient outcomes in robotic partial nephrectomy and prostatectomy
  • Supporting open, laparoscopic, and robotic procedures

What Physicians Need to Know

DICOM Support & Standards
Ceevra Reveal 3 supports DICOM, HL7, and FHIR standards for data exchange.
PACS Integration Method
Integration involves hospital IT staff installing Ceevra software on end-user computers and connecting it to the hospital's PACS. Patient CT/MRI scans are then uploaded to Ceevra's HIPAA-compliant cloud for 3D model generation.
Reading Room Workflow Impact
The system is designed for easy implementation with minimal IT involvement. Surgeons' assistants upload patient CT/MRI scans, and Ceevra generates 3D models. Surgeons can then view these interactive 3D models on various devices (computers, phones, tablets, surgical robotic displays) for preoperative planning and intraoperative visualization, aiming to reduce administrative burden.
AI Model Architecture (deep learning approach)
Ceevra Reveal 3 utilizes AI-driven software and machine learning algorithms to automatically generate 3D models and segment normal anatomy from CT and MRI scans. These algorithms are specifically used for adult patients (22 and over).
Processing Speed (per study)
Ceevra generates 3D models within two business days after the patient's CT/MRI is uploaded.
FDA Clearance Pathway (510k/De Novo)
Ceevra Reveal 3 (K222676) and Ceevra Reveal 3+ (K233568) are FDA 510(k) cleared Class II medical devices.
Supported Modalities (CT/MRI/X-ray/US)
The software processes multi-dimensional digital images acquired from CT and MRI imaging devices.
Sensitivity & Specificity Data
The device has been validated using diverse patient and scanner datasets, demonstrating high performance in segmenting various anatomical structures. For Ceevra Reveal 3+, measurement features (volumes, diameters, distances) were verified to be accurate within a mean difference of +/- 10% on phantom and patient datasets.
Physician Tip

Ceevra Reveal 3 offers interactive 3D models from CT and MRI scans, significantly enhancing preoperative planning and intraoperative visualization for various surgical specialties. The ability to selectively show/hide anatomical structures and view models on mobile devices or VR headsets provides a comprehensive understanding of complex patient anatomy. This can improve surgical decision-making, patient counseling, and potentially lead to better patient outcomes. The AI-driven segmentation is primarily for adult patients, and the rapid model generation within two business days supports timely planning.

Ceevra Reveal 3 integrates with existing hospital PACS systems, requiring initial setup by hospital IT. The workflow involves uploading DICOM-compliant CT/MRI data to Ceevra's HIPAA-compliant cloud for processing. The generated 3D models are then accessible on various end-user devices, including computers, mobile phones, tablets, and surgical robotic displays, ensuring broad accessibility within the clinical environment. The platform also adheres to HL7 and FHIR data standards.

Details

Category Radiology & Imaging AI, Surgical AI
Pricing Subscription model; contact vendor for details.
  • Subscription-based pricing tailored to customer needs; price depends on estimated number of scans per year, CT or MRI; tiers based on anticipated volume; subscriptions can combine multiple surgical specialties and hospitals; no one-time or variable fees
DeploymentSaaS
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Ceevra Reveal 3 (K222676) is an FDA-cleared medical imaging system intended for processing, review, analysis, communication, and media interchange of multi-dimensional digital images from CT or MR imaging devices. It includes preliminary segmentations of normal anatomy using machine learning and other computer vision algorithms, and is intended for preoperative surgical planning and intraoperative display for adult patients (22 and over).

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

What the Web Says

Ceevra Reveal 3 is an FDA-cleared, AI-driven software that transforms CT and MRI scans into interactive 3D models for surgical planning and intraoperative visualization. It is designed to assist healthcare professionals in various surgical specialties, including thoracic, urologic, general, HPB, and gynecologic surgeries. The software aims to improve surgical outcomes, reduce operative time, blood loss, and hospital stays, and enhance patient understanding and reduce anxiety.

Overall: Positive

Strengths

  • Saves time in the operating room by allowing surgeons to plan cases and identify anatomical variations beforehand.
  • Provides a much better understanding of patient anatomy and pathology compared to 2D scans.
  • Improves surgical skills, efficiency, and safety.
  • Reduces operative time, blood loss, and patient hospital stay duration.
  • Enhances patient counseling and understanding, potentially reducing anxiety and influencing patient choice of provider.
  • Easy to implement and use, requiring minimal effort from hospital IT personnel.

Limitations

  • Perceptions of the technology vary based on familiarity and prior use.
  • Potential limitations due to unknown costs and time for model acquisition.
  • Machine learning algorithms are currently only for adult patients (22 and over).

Based on reviews from: HealthAidb, PMC (PubMed Central), X-ray Interpreter, accessdata.fda.gov, Innolitics, Ceevra.com, The AdventHealth Blog, The Bleeding Edge of Digital Health, Sarasota Memorial Health Care System

Last updated: 2026-07-20

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Press & Coverage

X-ray Interpreter
Ceevra Reveal 3+ | FDA Radiology AI Device - X-ray Interpreter
Ceevra Reveal 3+ is an FDA-cleared software medical device that processes 3D images from CT and MR scans using machine learning to generate segmentations of normal anatomy, aiding in preoperative surgical planning and intraoperative visualization.
2025-03
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, supporting clinicians in preoperative planning and intraoperative visualization across various surgical specialties.
2025-10
Innolitics
Ceevra Reveal 3+ (K243933) u2014 FDA 510(k) - Innolitics
This FDA 510(k) premarket notification details the Ceevra Reveal 3+ as a medical imaging system for processing, review, and analysis of multi-dimensional digital images from CT or MR, including AI-driven preliminary segmentations for surgical planning.
2025-03
PubMed (Cureus)
A Comprehensive Review of Food and Drug Administration (FDA)-Cleared Virtual Reality Technologies in Radiology - PubMed
Ceevra Reveal 3+ is highlighted in a comprehensive review of FDA-cleared virtual reality systems in radiology, emphasizing its role in visualizing, manipulating, and interpreting radiological data for enhanced diagnostic precision and procedural planning.
2025-06
PMC (Journal of Medical Internet Research)
Advances in the Application of Threeu2010Dimensional Reconstruction in Thoracic Surgery: A Comprehensive Review - PMC
Ceevra Reveal 3 is listed as a closed-source, FDA-cleared platform utilizing machine learning and computer vision algorithms for 3D reconstruction in thoracic surgery, aiding in preoperative planning.
2025-08
AJR Online (American Journal of Roentgenology)
Opportunistic Screening on Chest CT, From the AJR Special Series on Screening - AJR Online
Ceevra Reveal 3+ is mentioned as an FDA-approved AI tool for segmentation and preoperative planning in a review discussing established and emerging imaging biomarkers derived from chest CT scans.
2025-07
Journal of Thoracic Disease
3-dimensional reconstruction and mixed reality in thoracic surgery: a narrative review and user guide
Ceevra Reveal 3+ is included in a review of 3D reconstruction platforms for thoracic surgery, noting its AI-assisted VR capabilities for preoperative planning, accessible via various devices.
2025-12
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.
2023-11

Videos

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Frequently Asked Questions

Ceevra Reveal 3 is designed for straightforward integration; hospital IT staff installs the software and connects it to the hospital's PACS. Your assistant then uploads patient CT/MRI scans to Ceevra's HIPAA-compliant cloud, and Ceevra generates the 3D model within two business days for you to view on various devices.
Ceevra Reveal 3 is FDA-cleared and CE Marked, indicating it meets specific regulatory standards for medical devices. The platform operates with a HIPAA-compliant cloud for data handling, ensuring patient data privacy and security during the upload and processing of imaging studies.
Yes, the machine learning algorithms within Ceevra Reveal 3 are specifically intended for use with adult patients aged 22 and over. For patients under 22 or of unknown age, 3D images will still be generated, but without the use of these particular machine learning algorithms.
Ceevra Reveal 3 has been validated using diverse patient and scanner datasets, demonstrating high performance in segmenting anatomical structures. Furthermore, two randomized clinical trials have shown that using Ceevra 3D models can lead to substantial improvements in patient outcomes for procedures like robotic partial nephrectomy and robotic prostatectomy.
Ceevra Reveal 3 is offered through an annual software subscription model. The pricing structure is tiered, depending on the estimated volume of CT or MRI scans a practice or hospital anticipates utilizing per year, with no additional one-time or variable fees.
Several other platforms offer 3D visualization and surgical planning capabilities, including ImmersiveTouch/ImmersiveAR, PulmoVR, 3D Slicer, Simpleware, Invivo5, and Materialise Mimics Care Suite. These alternatives vary in their features, such as AI assistance, manual segmentation, and device compatibility.
Patient imaging data, typically CT or MRI scans in DICOM format, is deidentified and uploaded by hospital personnel to Ceevra's HIPAA-compliant cloud. Ceevra then uses its FDA-cleared machine learning and computer vision algorithms to process this data and generate detailed 3D models.

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Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20

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