|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Classification Name||imager, breast, electrical impedance|
|Applicant||MIRABEL MEDICAL SYSTEMS, INC.|
|Supplement Type||normal 180 day track|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for changes in the electronic circuitry, elimination of all but the 200 hz frequency, optional small probe, and optional phantom. The device is intended for use as an adjunct to mammography in patients who have equivocal mammographic findings within acr bi-rads(tm) categories 3 or 4. In particular, it is not intended for use in cases with clear mammographic or non-mammographic indications for biopsy. This device provides the radiologist with additional information to guide a biopsy recommendation.