510(k) K091877

CHISON DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED ARRAY PROBE, TRANSVAGINAL by Chison Medical Imaging Co., Ltd. — Product Code ITX

K091877 is an FDA 510(k) premarket notification submitted by Chison Medical Imaging Co., Ltd. for the device "CHISON DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED ARRAY PROBE, TRANSVAGINAL". The FDA issued a decision of Substantially Equivalent on Sep 2, 2009. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Chison Medical Imaging Co., Ltd. has 12 other 510(k) clearances on record.