510(k) K891452

SPECTRA ULTRASOUND SYSTEM W/COLOR FLOW MODULE by Diasonics, Inc. — Product Code IYO

K891452 is an FDA 510(k) premarket notification submitted by Diasonics, Inc. for the device "SPECTRA ULTRASOUND SYSTEM W/COLOR FLOW MODULE". The FDA issued a decision of Substantially Equivalent on June 7, 1989. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Diasonics, Inc. has at least 10 other 510(k) clearances on record.