510(k) K002807

3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING by Acuson Corp. — Product Code IYO

K002807 is an FDA 510(k) premarket notification submitted by Acuson Corp. for the device "3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING". The FDA issued a decision of Substantially Equivalent on December 1, 2000. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Acuson Corp. has at least 10 other 510(k) clearances on record.