510(k) K861931

645OB SECTOR/LINEAR ULTRASOUND SCANNER by Ge Medical Systems Information Technologies — Product Code HEM

K861931 is an FDA 510(k) premarket notification submitted by Ge Medical Systems Information Technologies for the device "645OB SECTOR/LINEAR ULTRASOUND SCANNER". The FDA issued a decision of SN on July 31, 1986. The device falls under product code HEM (Imager, Ultrasonic Obstetric-Gynecologic), a Class II device regulated under 21 CFR 884.2225. Ge Medical Systems Information Technologies has at least 10 other 510(k) clearances on record.