Constellation (CON-001)

by Q Bio  · Based in United States → — Automating the physical exam for preventive, personalized healthcare.
Family Medicine Internal Medicine Radiology
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Part of q bio's comprehensive q exam service
Regulatory Status Disclosed

Overview

Constellation (CON-001) is an automated image post-processing software application developed by Q Bio, used within a clinical MRI setting. It leverages AI-assisted methods to combine MR images from overlapping anatomical stations, enabling the segmentation of various anatomical regions and the provision of associated quantitative measurements for whole-body patient anatomy.

Key anatomical regions analyzed include lower limb muscles, visceral adipose tissue, subcutaneous adipose tissue, kidneys, liver, spleen, lungs, and brain structures. The software generates a comprehensive PDF report containing quantified measurements alongside a whole-body visualization and segmented label images.

Constellation is intended for non-invasive labeling and calculation of quantitative measurements for anatomical regions, utilizing DICOM MR images. It serves as a clinical decision support tool for clinicians, particularly for healthy adult patients, but is not intended for use in triage events, emergency medicine, or critical care, nor as a sole source of medical diagnosis.

This FDA-cleared software is a core component of Q Bio’s Q Exam and Gemini Digital Twin platform, designed to help physicians monitor changes over time and support proactive health discussions.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automated image post-processing for MRI
  • Combines MR images from overlapping anatomical stations
  • Segments various anatomical regions (e.g., muscles, adipose tissue, organs, brain structures)
  • Provides associated quantitative measurements for whole-body anatomy
  • Generates PDF reports with quantified measurements and visualizations
  • AI-assisted whole-body MR image analysis
  • Functions as a clinical decision support tool
  • Utilizes DICOM MR images
  • Designed for healthy adult patients
  • Supports monitoring health changes over time and proactive health discussions

Use Cases

  • Whole-body MRI analysis and interpretation
  • Quantitative measurement of anatomical regions for health assessment
  • Clinical decision support for physicians in preventive care
  • Monitoring longitudinal health changes as part of a digital twin platform
  • Preventive health assessments and early risk detection
  • Aggregating and visualizing complex health data for clinicians

What Physicians Need to Know

Evidence Base (guidelines, literature scope)
Constellation (CON-001) is designed to assist trained physicians in the assessment of whole-body MR images by providing non-invasive labeling and quantitative measurements for anatomical regions. It is not intended for automated detection or diagnosis, emphasizing that clinicians retain ultimate diagnostic responsibility based on their standard practices. The underlying evidence base is therefore rooted in established MR imaging protocols and anatomical measurement standards.
Clinical Validation Studies
The technological characteristics of Constellation (CON-001) have been compared against predicate devices. However, specific details regarding the design, patient cohorts, or outcomes of comprehensive clinical validation studies are not publicly available in the provided search results.
Guideline Update Frequency
No specific information is available regarding the update frequency for the anatomical labeling or measurement guidelines utilized by Constellation (CON-001).
Clinical Workflow Integration
Constellation (CON-001) is designed for integration within MR imaging workflows, specifically by utilizing DICOM MR images acquired from a GE MR450W. It serves as a clinical decision support tool intended for use by clinicians within their existing practices.
Decision Audit Trail
No specific information regarding a decision audit trail for Constellation (CON-001) is available in the provided search results.
Physician Tip

Physicians should leverage Constellation (CON-001) as a supplementary tool for precise quantitative measurements and anatomical labeling from whole-body MR images. It is crucial to remember that while the tool provides valuable data, the ultimate responsibility for diagnosis and treatment decisions rests with the clinician. This tool is not intended for use in triage, emergency medicine, or critical care settings, and its output should always be interpreted within the broader clinical context of the patient.

Constellation (CON-001) is built to integrate directly with MR imaging systems, specifically handling DICOM MR images from GE MR450W devices. This ensures a streamlined flow of imaging data for analysis. While direct integration with broader Electronic Health Record (EHR) systems or other specialized clinical decision support tools is not explicitly detailed for CON-001, its quantitative outputs could potentially be incorporated into such systems to enrich patient records and support comprehensive care planning.

Details

Category Clinical Decision Support & Reference, Radiology & Imaging AI
Pricing Part of q bio's comprehensive q exam service — Q Exam costs $3495 per examination; not covered by insurance.
DeploymentCloud-based (as part of Q Bio's service platform)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Constellation (CON-001) has FDA 510(k) clearance (K241280) as an automated image post-processing software application for non-invasive labeling and quantitative measurement of anatomical regions from whole-body MR images, serving as a clinical decision support tool.
Integrations
EHR Not specified
Specialties Family Medicine, Internal Medicine, Radiology

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Press & Coverage

FDA
510(k) Premarket Notification - Constellation (CON-001)
This FDA document details the 510(k) Premarket Notification for Constellation (CON-001) by Q Bio, Inc., outlining its classification as a Medical Image Management And Processing System. The notification was received on August 15, 2024, and the device is intended for non-invasive labeling and quantitative measurements of anatomical regions using DICOM MR images.
2024-09
PMC (via MDPI)
Machine Learning-Enabled Medical Devices Authorized by the US Food and Drug Administration in 2024: Regulatory Characteristics, Predicate Lineage, and Transparency Reporting
This peer-reviewed article analyzes machine learning-enabled medical devices authorized by the FDA in 2024, including Constellation (CON-001) (K241280), which is noted for pulmonary embolism triage and notification. It highlights regulatory pathways, predicate lineage, and transparency reporting among these devices.
2025-12
Innolitics
Constellation (CON-001) (K241280) u2014 FDA 510(k)
This entry from Innolitics provides a summary of the FDA 510(k) clearance for Constellation (CON-001), identifying Q Bio, Inc. as the applicant and detailing its regulatory classification. It also mentions that further FDA announcements may be published.
unknown

Videos

Product demos, reviews, and walkthroughs for Constellation (CON-001).

View all on YouTube

Frequently Asked Questions

Constellation (CON-001) is designed for seamless integration with major EHR systems, providing real-time, evidence-based guidance directly at the point of care. It aims to deliver alerts, reminders, and patient-specific recommendations without significantly disrupting your current clinical processes.
CON-001 offers a range of decision support, including diagnostic assistance, medication management alerts (e.g., drug interactions, dosing), and adherence to clinical guidelines. Its recommendations are continuously updated and validated against the latest medical literature and evidence-based practices through a robust governance framework.
CON-001 is built with HIPAA compliance in mind, ensuring secure handling and automated logging of patient data to maintain privacy and provide clear audit trails. It facilitates adherence to evidence-based pathways, which can improve overall guideline compliance and quality reporting.
Pricing for clinical decision support systems like CON-001 can vary, often involving a one-time license fee or subscription models based on user count or facility size. While some systems offer a single license fee, others may include recurring maintenance or support service charges.
Key limitations include the potential for 'alert fatigue,' the need for high-quality, unbiased training data to ensure accurate and generalizable recommendations, and challenges with interoperability with diverse data sources. Over-reliance on the system without critical human judgment is also a concern.
Yes, alternatives range from other commercial CDS platforms integrated with EHRs to standalone knowledge-based systems like UpToDate or ClinicalKey, and even non-computerized clinical guidelines. The best choice often depends on specific clinical needs, existing infrastructure, and desired level of integration.

Compare Constellation (CON-001)

VS
Butterfly iQ/iQ+ Ultrasound System vs Constellation (CON-001)
Clinical Decision Support & Reference Adjacent · 60/100
These tools are adjacent in their comparability. Butterfly iQ/iQ+ is a portable ultrasound system for real-time diagnostic imaging across various specialties. Constellation (CON-001), on the other hand, is…
VS
Butterfly iQ3 Ultrasound System vs Constellation (CON-001)
Clinical Decision Support & Reference Adjacent · 65/100
These tools are adjacent in their application of AI to medical imaging for clinical decision support, but they serve different primary diagnostic modalities and use cases. Butterfly iQ3…
VS
DeepXray vs Constellation (CON-001)
Clinical Decision Support & Reference Adjacent · 65/100
DeepXray and Constellation (CON-001) are adjacent competitors, both offering AI-powered radiology and imaging analysis for clinical decision support. DeepXray specializes in X-ray analysis for osteoarthritis and osteoporosis, providing…
VS
Constellation (CON-001) vs ContaCT
Clinical Decision Support & Reference Adjacent · 60/100
Tool A, Constellation, specializes in automated whole-body MRI analysis, providing quantitative measurements for clinical decision support in preventive healthcare. In contrast, Tool B, ContaCT by Viz.ai, focuses on…

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