Product Classification

• 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 Code: OEE
• Premarket Review: Office of 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 Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible