> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Medical Image Analyzers Reclassified into Class 2
- URL: https://www.fdaweb.com/medical-image-analyzers-reclassified-into-class-2/
- Published: 2018-06-04T12:00:00.000Z
- Updated: 2026-09-15T00:10:12.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141588

*Federal Register* notice: FDA has issued a proposed order to reclassify medical image analyzers applied to mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection from postamendments Class 3 (premarket approval) devices into Class 2 (special controls), subject to premarket notification. The devices are intended to direct a clinician’s attention to portions of an image that may reveal abnormalities during interpretation of patient’s radiology images by the clinician. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-06-04/pdf/2018-11880.pdf?ref=fdaweb.com).