OPGAL INTRAOPERATIVE VASCULAR ANGIOGRAPHY SYSTEM (IVA-2000)

OPGAL INTRAOPERATIVE VASCULAR ANGIOGRAPHY SYSTEM (IVA-2000) is an FDA 510(k)-cleared medical device (K951806) manufactured by Opgal Optronic Industries. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 5, 1995. Regulation: 8.