QDQ

37 FDA 510(k) clearances · Product code

FDA profile

Official device name

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

Device class

Class II (moderate risk)

Regulation

21 CFR 892.2090

Medical specialty

Radiology

FDA definition

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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