Evaluation of RFID Localization System for Marking and Retrieving Breast Lesions

A Prospective, Single-Arm, Multicenter Clinical Study to Evaluate the Safety and Performance of the Health Beacons Radiofrequency Identification (RFID) Localization System for Marking and Retrieving Non-Palpable Breast Lesions

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