LAPAROSCAN(TM) INTRAOPER DIAG ULTRASOUND SYSTEM

LAPAROSCAN(TM) INTRAOPER DIAG ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K913472) manufactured by Baxter Healthcare Corp. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 12, 1992. Regulation: 8.