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# CADx Software for Suspect Cancer Lesions Into Class 2
- URL: https://www.fdaweb.com/cadx-software-for-suspect-cancer-lesions-into-class-2/
- Published: 2020-01-22T12:00:00.000Z
- Updated: 2026-09-14T15:59:38.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145897

*Federal Register* notice: FDA has classified the radiological computer-assisted diagnostic (CADx) software for lesions suspicious for cancer into Class 2 (special controls). The classification was made after Quantitative Insights submitted a *de novo* request for its QuantX device. FDA identified the product as an image processing device intended to aid in the characterization of lesions as suspicious for cancer identified on acquired medical images such as magnetic resonance, mammography, radiography, or computed tomography. It characterizes lesions based on features or information extracted from the images and provides information about the lesion(s) to the user. Diagnostic and patient management decisions are made by the clinical user. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-01-22/pdf/2020-00497.pdf?ref=fdaweb.com).