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# Medical Image Analyzers Reclassified as Class 2
- URL: https://www.fdaweb.com/medical-image-analyzers-reclassified-as-class-2/
- Published: 2020-01-22T12:00:00.000Z
- Updated: 2026-09-14T15:59:37.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145898

*Federal Register* notice: FDA has issued an order to reclassify medical image analyzers, including CADe devices, for mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection from Class 3 to Class 2 (special controls). The order assigns such devices the generic name medical image analyzer, and identifies them as intended to identify, mark, highlight, or in any other manner direct the clinicians’ attention to portions of a radiology image that may reveal abnormalities during interpretation of patient radiology images by the clinicians. The device incorporates pattern recognition and data analysis capabilities and operates on previously acquired medical images. To view the order, click [here](https://www.govinfo.gov/content/pkg/FR-2020-01-22/pdf/2020-00494.pdf?ref=fdaweb.com).