Not required to be registered

The goal of this investigation is to obtain clinical data to show the Health Beacons Radiofrequency Identification (RFID) Localization System is safe and performs as intended as a localization device for marking and retrieving a non-palpable surgical target from the breast.

Inclusion Criteria:

• Have had stereotactic or ultrasound-guided biopsy with marker placement
• Have a lesion or biopsy marker that is visible under ultrasound
• Have surgical target < 6 cm from the skin when lying supine
• Have a discreet surgical target
• Have a lesion in which the center/focal area is defined
• Be at least 18 years of age or older

Exclusion Criteria:

• Have a palpable lesion that does not require localization
• Require more than one localization needle for localization of the surgical target
• Have undergone previous open surgical biopsy or lumpectomy in the operative breast
• Have an implant in the operative breast
• Have a cardiac pacemaker or defibrillator device

Female patients