MammoReader - P010038
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: MammoReader
Manufacturer: Intelligent Systems Software, Inc.
Address: 311 Park Place Blvd., Suite 240, Clearwater, FL 33759
Approval Date: January 15, 2002
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf/P010038a.pdf
What is it? The MammoReader is a Computer-Aided Detection (CAD) system that helps radiologists who read mammograms to highlight areas that might be suspicious for breast cancer and might otherwise be missed.
How does it work? The system uses computing equipment and a special x-ray film scanner that changes the image on the mammogram into digital data. The device uses these data to locate areas suspicious for cancer of the breast.
For a drawing of the breast with some expected disorders go to:
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 MammoReader. This way, the MammoReader 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 MammoReader helps the radiologist detect cancers that might otherwise have been overlooked. The MammoReader 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 MammoReader 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. The key warnings for radiologists who use this device are the following:
- review the films in the usual manner first, before reviewing the MammoReader system results;
- do not refrain from taking further action regarding a suspicious breast area simply because the MammoReader did not mark that region;
- since most marked locations do not indicate cancer, decide if further action is required based on the reading of the mammogram, after examining the areas marked by the MammoReader; and
- remember that the MammoReader aids in detecting suspicious areas for re-examination; it is not the primary basis for decisions on those areas.
Additional information: Summary of Safety and Effectiveness and labeling are available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=P010038