Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
QDQ · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.2090
Classification
FDA Product Code
QDQ
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 892.2090
Review panel
RA
Medical specialty
Radiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.