FDA has issued a final order to reclassify:
- medical image analyzers applied to mammography breast cancer
- ultrasound breast lesions
- radiograph lung nodules
- radiograph dental caries detection
all which are post-amendments 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.
These devices (generic name: medical image analyzer including CADe devices) are 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. This device incorporates pattern recognition and data analysis capabilities and operates on previously acquired medical images. This device is not intended to replace the review by a qualified radiologist and is not intended to be used for triage or to recommend diagnosis.