Radiology
Genius AI Detection 2.0 with CC-MLO Correlation
Hologic, Inc.
A radiological computer assisted detection and diagnostic software for suspected lesions is an image processing device intended to aid in the detection, localization, and characterization of lesions suspicious for cancer on acquired medical images (e.g., mammography , MR, CT, ultrasound, radiography). The device detects, identifies and characterizes lesions suspicious for cancer based on features or information extracted from the images, and may provide information about the presence, location, and characteristics of the lesion to the user. Primary diagnostic and patient management decisions are made by the clinical user.
FDA Submission Metadata
- Submission number
- K230096
- Decision date
- May 2023
- FDA panel
- Radiology
- Product code
- QDQ
- Clinical task (npj)
- detection/diagnosis
- Data modality (npj)
- Images
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
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