Qlarity Imaging Information

Qlarity Imaging improves patient care with our AI-driven technology, QuantX™. The first FDA-cleared diagnostic AI software, QuantX™ helps improve radiologist performance during breast MRI interpretation. By extracting and analyzing data from breast MR images to enhance decision making, QuantX™ provides value to radiologists, health systems, and most importantly patients. Indication: QuantX™ is indicated for the assessment and characterization of breast abnormalities from MRI data in patients presenting for high-risk screening, diagnostic imaging workup, or evaluation of extent of known disease. QuantX™ is not intended for primary interpretation of digital mammography images. Risk Information: QuantX™ is not intended for primary interpretation of digital mammography images. Labeling also provides information to users about potential limitations of the device related to specific subpopulations. For use by licensed healthcare professionals only.