OEW

Tracking, Soft Tissue, Intraoperative

Product code

OEW

Device name

Tracking, Soft Tissue, Intraoperative

Device class

Class 2

21 CFR

21 CFR 882.4560

Medical specialty

Neurology

Marketing pathway

510(K)

Flag

Life-sustaining / life-supporting

510(k) clearances (last 3 years)

4

FDA classification definition

For open liver surgical procedures where image-guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.

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