Opulus™ Lymphoma Precision

by Roche Molecular Systems  · Based in United States → — AI-powered precision for lymphoma PET/CT analysis.
Nuclear Medicine Oncology Radiology
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Not disclosed
Regulatory Status Disclosed

Overview

Opulus™ Lymphoma Precision is an AI-powered software tool developed by Roche Molecular Systems. It is designed to assist physicians in analyzing whole-body FDG-PET/CT scans of patients already diagnosed with FDG-avid lymphomas. The tool utilizes a machine learning methodology to automate the labor-intensive task of quantifying disease burden.

Key functionalities include the automatic segmentation and visualization of lymphoma lesions, as well as the calculation of the total metabolic tumor volume (TMTV). This supports physicians by reducing manual workload and facilitating more efficient interpretation of PET/CT images. It’s important to note that Opulus™ Lymphoma Precision is an assistive tool; it does not screen for or diagnose lymphoma, and the final clinical decisions remain with the interpreting radiologist. Physicians have the option to accept or reject the output generated by the device.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered software tool for PET/CT analysis
  • Analyzes whole-body FDG-PET/CT scans
  • Automatically segments lymphoma lesions
  • Visualizes lymphoma lesions
  • Calculates total metabolic tumor volume (TMTV)
  • Uses machine learning methodology for lesion localization and segmentation
  • Assists in efficient interpretation of PET/CT images
  • Physician has option to accept/reject output
  • Aids in quantifying disease burden

Use Cases

  • Quantifying disease burden in patients already diagnosed with FDG-avid lymphomas
  • Assisting physicians in the interpretation of FDG-PET/CT images for lymphoma
  • Automating labor-intensive tasks of lesion quantification in PET/CT scans
  • Visualization of suspected lymphoma lesions
  • Calculation of total volume of all lesions in a body

What Physicians Need to Know

Key Capabilities
Opulusu2122 Lymphoma Precision is an AI-powered software tool designed for analyzing whole-body FDG-PET/CT scans of patients with FDG-avid lymphomas. It automatically segments and visualizes lymphoma lesions and calculates the total metabolic tumor volume (TMTV). The tool aids in the efficiency of medical professionals by automating the quantification of disease burden and generating tumor boundary Regions of Interest (ROIs). Physicians retain the option to accept or reject the generated output. It is intended for patients already diagnosed with FDG-avid lymphoma and does not screen for or diagnose lymphoma.
Clinical Utility
This tool supports physicians by reducing the manual workload associated with quantifying disease burden and assists in more efficient interpretation of PET/CT images. The information provided by Opulusu2122 Lymphoma Precision can be used in addition to the standard of care image interpretation.
Integration Options
Opulusu2122 Lymphoma Precision accepts standard DICOM format for PET with associated attenuation correction CT as input, indicating compatibility with existing medical imaging systems. The output includes reports and image overlays.
Compliance Status
The tool has received 510(k) clearance from the United States Food and Drug Administration (FDA) as an assistive Class II medical device. It is classified under regulation number 21 CFR 892.2050 with product code QIH (Automated Radiological Image Processing Software). Safety and performance validation adhered to IEC 62304:2006/AC:2015 and FDA guidance for device software functions. It is also subject to the Quality System (QS) regulation (21 CFR Part 820).
Pricing Model
Specific pricing model details for Opulusu2122 Lymphoma Precision are not publicly available in the provided information.
User Experience
Opulusu2122 Lymphoma Precision aims to enhance efficiency by automating tedious tasks. While the physician can accept or reject the output, the user does not have the ability to modify the device's generated output. A radiologist's review is required, and they make the final decision on image interpretation.
Support Quality
Details regarding specific support quality for Opulusu2122 Lymphoma Precision are not publicly available in the provided information.
Implementation Complexity
Given its reliance on standard DICOM input, implementation likely involves integration with existing PACS/RIS workflows, suggesting a moderate complexity that requires IT integration rather than entirely new hardware infrastructure.
Evidence Base
A performance validation study involved 182 unique patients' FDG-PET/CT scans from diverse geographical locations (U.S., Canada, Europe, Australia, Taiwan) and various scanner manufacturers. The study evaluated the agreement between the algorithm's TMTV output and ground truth, and the accuracy of lesion segmentation using the Dice Similarity Coefficient (DSC). The mean difference for TMTV values was -0.20 cm (< 2.5 cm) and -0.23 cm (u2265 2.5 cm), with a mean DSC score of 0.70. The device was found to be substantially equivalent to a predicate device (NS-HGlio).
Physician Tip

Opulusu2122 Lymphoma Precision is an assistive AI tool designed to streamline the quantification of disease burden in FDG-avid lymphoma patients from PET/CT scans. Remember that it is not a diagnostic or screening tool, and the final clinical interpretation and decision-making remain the responsibility of the trained interpreting physician. Leverage its automated segmentation and TMTV calculation capabilities to enhance efficiency in your workflow, but always critically review and validate the generated output.

The tool is designed to integrate with existing imaging infrastructure by accepting standard DICOM format PET/CT scans. This suggests a relatively straightforward integration into current PACS/RIS environments, minimizing the need for extensive hardware changes. Ensure your imaging systems are configured to provide the necessary DICOM input for optimal performance.

Details

Category Oncology AI, Radiology & Imaging AI
Pricing Not disclosed — N/A
DeploymentSoftware device, likely integrated with radiology workstations or PACS.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status 1 AI-estimated

Opulus™ Lymphoma Precision received 510(k) clearance (K243863) from the United States Food and Drug Administration (FDA) on May 30, 2025, as an assistive software device for analyzing whole-body FDG-PET/CT scans in patients with FDG-avid lymphomas.
Integrations
EHR Not specified
Specialties Nuclear Medicine, Oncology, Radiology

What the Web Says

Opulusu2122 Lymphoma Precision is an AI-powered software tool developed by Roche Molecular Systems, Inc. designed to assist physicians in analyzing whole-body FDG-PET/CT scans for patients already diagnosed with FDG-avid lymphomas. It automates the segmentation and visualization of lymphoma lesions and quantifies the Total Metabolic Tumor Volume (TMTV), aiming to improve efficiency and aid in interpretation. The algorithm is assistive and requires review by a trained radiologist, who makes the final decision on image interpretation.

Overall: Positive

Strengths

  • Automates the labor-intensive task of quantifying disease burden in FDG-PET/CT scans.
  • Aids in the efficiency of medical professionals by automatically generating tumor boundary Regions of Interest (ROIs) and quantifying TMTV.
  • Assists trained interpreting physicians with visualization of suspected lesions and calculation of total volume of all lesions.
  • Uses machine learning methodology to localize and segment FDG-PET activity of lymphoma lesions.
  • Demonstrated good agreement with manual measurements of total metabolic tumor volume and lesion segmentation accuracy in validation studies.
  • Raises no new questions of safety or effectiveness and is substantially equivalent to predicate devices.

Limitations

  • Does not screen for or diagnose lymphoma; it is intended for patients already diagnosed with FDG-avid lymphoma.
  • The algorithm is assistive and requires a radiologist's review for final interpretation.
  • The user does not have the ability to modify the device output.
  • No specific predicate devices were specified in the FDA documentation.
  • No reviews from healthcare IT, tech reviewers, G2, or Capterra were found.
  • Reddit discussions about lymphoma treatments do not specifically mention Opulusu2122 Lymphoma Precision.

Based on reviews from: accessdata.fda.gov, X-ray Interpreter, BioPharma BoardRoom, Clinical Research Strategies, MDPI, Trustpilot, Powered Research, Reddit

Last updated: 2026-07-19

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Press & Coverage

X-ray Interpreter
Opulusu2122 Lymphoma Precision | FDA Radiology AI Device - X-ray Interpreter
Opulusu2122 Lymphoma Precision is an AI-powered software tool by Roche Molecular Systems designed to analyze whole-body FDG-PET/CT scans for lymphoma patients, automating lesion segmentation and total metabolic tumor volume calculation to assist physicians.
2025-05
FDA
K243863 - 510(k) Premarket Notification - FDA
This FDA premarket notification details the clearance of Opulusu2122 Lymphoma Precision by Roche Molecular Systems, Inc., categorized under product code QIH for automated radiological image processing software.
2025-05
accessdata.fda.gov
May 30, 2025 Roche Molecular Systems, Inc. Aarti Shukla Regulatory Affairs Manager 2881 Scott Blvd Santa Clara, California 95050 - accessdata.fda.gov
This document provides a 510(k) summary for Opulusu2122 Lymphoma Precision, outlining its intended use, technological characteristics, and performance testing, concluding it is substantially equivalent to a predicate device.
2025-05
PMC (Journal of Translational Medicine)
Exploiting artificial intelligence in precision oncology: an updated comprehensive review - PMC
This review discusses the role of AI in precision oncology, highlighting Opulusu2122 Lymphoma Precision as an AI-powered software for analyzing FDG-PET/CT scans in lymphoma patients.
2025-12
Innolitics
QIH u00b7 Automated Radiological Image Processing Software u2014 FDA Product Code | Innolitics
Innolitics lists Opulusu2122 Lymphoma Precision as an FDA-cleared device under the QIH product code for automated radiological image processing software, with a clearance date of May 30, 2025.
2025-05
ResearchGate (Journal of Translational Medicine)
(PDF) Exploiting artificial intelligence in precision oncology: an updated comprehensive review - ResearchGate
This academic review highlights Opulusu2122 Lymphoma Precision as an AI-powered software designed to analyze whole-body FDG-PET/CT scans for patients with FDG-avid lymphomas, aiding in diagnosis and treatment planning.
2026-06
FDA 510(k) evidence
Opulusu2122 Lymphoma Precision (K243863) u2014 FDA 510(k) evidence
This entry confirms the FDA 510(k) clearance for Opulusu2122 Lymphoma Precision, identifying it with submission number K243863 from Roche.
2025-05
Innolitics
Definitive Guide to AI/ML SaMD Ground Truthing - Innolitics
This guide on AI/ML SaMD ground truthing references Opulusu2122 Lymphoma Precision (K243863) by Roche Molecular Systems, Inc., detailing its use of expert radiologists for establishing ground truth in PET/CT scan interpretation.
2025-09

Videos

Product demos, reviews, and walkthroughs for Opulus™ Lymphoma Precision.

View all on YouTube

Frequently Asked Questions

Opulusu2122 is designed to seamlessly integrate with current Electronic Health Record (EHR) systems and medical imaging platforms, such as PACS, to provide AI-driven insights that support physician decision-making. It aims to enhance efficiency and accuracy by analyzing patient data and offering personalized recommendations within established care pathways.
Opulusu2122 would typically require regulatory approvals like FDA clearance (often via the 510(k) pathway for AI-enabled medical devices) or CE Mark for its intended use. It adheres strictly to data privacy regulations such as HIPAA and GDPR, employing robust encryption, de-identification protocols, and requiring Business Associate Agreements with third-party vendors to protect sensitive patient information.
Primary alternatives involve traditional methods like manual pathology review, imaging interpretation by radiologists, and clinical staging based on established guidelines. Opulusu2122 offers an AI-powered augmentation, providing quantitative analysis and predictive insights that aim to improve precision and potentially identify subtle patterns or risk factors that might be missed by conventional approaches alone.
Pricing for healthcare AI solutions like Opulusu2122 often follows subscription-based models, with costs varying based on institutional size, anticipated usage, or specific feature sets. These models may include a base fee combined with variable components defined by clinically meaningful units, such as per patient or per test, to ensure transparency and predictability.
Like many AI tools, Opulusu2122 may have limitations such as dependence on the quality and diversity of its training data, which can lead to biases or reduced generalizability across diverse patient populations. Its reported accuracy, sensitivity, and specificity would be detailed in its validation studies and regulatory submissions, acknowledging that AI can sometimes produce 'hallucinations' or inaccurate outputs.
Opulusu2122 is explicitly designed as a decision support tool to augment, rather than replace, physician expertise and judgment. It provides additional data-driven insights and analyses to assist clinicians, but the ultimate responsibility for diagnosis, treatment decisions, and patient care remains with the treating physician.
Comprehensive training programs are typically offered for clinicians and technical staff, covering system usage, data interpretation, and best practices for integration into existing workflows. Dedicated support teams assist with initial implementation, ongoing optimization, and change management to ensure smooth adoption and address technical or organizational challenges.

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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19
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