510(k) K112953

TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICS by Teratech Corp. — Product Code IYN

K112953 is an FDA 510(k) premarket notification submitted by Teratech Corp. for the device "TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICS". The FDA issued a decision of Substantially Equivalent on Feb 3, 2012. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Teratech Corp. has 16 other 510(k) clearances on record.