Q Bio, Inc. radiology AI products

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Radiology AI pricing and total cost of ownership

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FDA-cleared K241280

Constellation (CON-001)

Q Bio, Inc.

Authorized purpose: Constellation is intended for non-invasive labeling and calculation of quantitative measurements for anatomical regions using whole-body DICOM MR images gathered on a GE MR450W. It is intended for healthy adult patients and may be used as a clinical decision-support tool, but not in triage events, emergency medicine, or critical care; a clinician retains responsibility for diagnosis.

Modality: MRI
Anatomy: Whole body including lower-limb muscles, visceral and subcutaneous adipose tissue, kidneys, liver, spleen, lungs, and brain structures
Decision: 2024-09-12