This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Kodak Mammography CAD ENGINE
Applicant:Eastman Kodak Company
Address:343 State Street , Rochester , NY 14650-1131
Approval Date: November 23, 2004
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030007a.pdf
What is it? The Kodak Mammography CAD (computer-aided design) ENGINE uses software that helps radiologists who read mammograms to highlight areas that might be suspicious for breast cancer and might otherwise have been missed.
How does it work?
- The Kodak system uses a commercially available mammogram film scanner to change the image into digital data.
- The system software uses these data to locate areas in the breast that are suspicious for cancer.
- The system software then displays these suspicious areas on a computer monitor.
When is it used? Before making a final patient diagnosis, the radiologist must first review each mammogram as usual and then re-examine the original films observing any suspicious areas marked by the CAD Engine. This way, CAD Engine reduces the number of missed cancers. This system can be used with any standard film/screen mammographic views.
What will it accomplish? Research studies have shown that the CAD Engine helps the radiologist detect cancers that might otherwise have been overlooked. The CAD Engine does increase the need for patients to have additional x-ray views, ultrasound examinations, and biopsies. Medical personnel, however, see this increase as acceptable since there is also an increase in cancers identified.
Although the CAD Engine alerts a radiologist to additional suspicious areas missed on the mammogram, the device may also fail to mark areas the radiologist identified on the mammogram. If this occurs, the radiologist is cautioned not change his or her decision about the suspicious areas he or she identified on the mammogram.
When should it not be used? There are no contraindications for this device.
Summary of Safety and Effectiveness and labeling is available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p030007