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Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

FDA product code QDQ · 40 cleared devices

Class 2 Radiology
Regulation
21 CFR 892.2090
Review panel
RA
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2018-11-21 – 2026-09-14

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.

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