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U.S. Department of Health and Human Services

Product Classification

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Device diagnostic low electric field
Definition As an adjunctive tool to guide the shavings of tissue at the margins of the tumor for use in excisional breast surgery to assist in locating the tissue for excision. In addition to other standard methods such as intraoperative imaging and palpation.
Physical State low electromagnetic field
Technical Method It utilizes electromagnetic waves to characterize human tissue in real-time. It consists of a console and a disposable hand-piece.
Target Area breast tumor
Review Panel General & Plastic Surgery
Product CodeOEE
Premarket Review Surgical and Infection Control Devices (OHT4)
General Surgery Devices (DHT4A)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible