Radiology Devices; Reclassification of Medical Image Analyzers
Information
Type
Rule
Regulated products
Published
January 22, 2020
Last updated
January 22, 2020
Description
Document number 2020-00494. The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify medical image analyzers applied to mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection, postamendments class III devices (regulated under product code MYN), into class II (special controls), subject to premarket notification. These devices are intended to direct the clinician's attention to portions of an image that may reveal abnormalities during interpretation of patient radiology images by the clinician. FDA is also identifying the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device type.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)