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U.S. Department of Health and Human Services

Product Classification

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Device radiological computer assisted detection/diagnosis software for lesions suspicious for cancer
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.
Physical State Software device that receives radiological images as an input and provides the user with the identification and characterization of suspicious lesions as an output.
Technical Method Analyzes radiological images using machine learning algorithms to detect and diagnose lesions suspicious for cancer.
Target Area Anatomical sites that may contain lesions suspicious for cancer.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeQDQ
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 892.2090
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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