OEE

Diagnostic Low Electric Field

Product code

OEE

Device name

Diagnostic Low Electric Field

Device class

Class 3

Medical specialty

Unknown

Marketing pathway

PMA

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).