510(k) K982610

OLYMPUS UM-2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT (URINARY TRACT) by Olympus Optical, Co. — Product Code ITX

K982610 is an FDA 510(k) premarket notification submitted by Olympus Optical, Co. for the device "OLYMPUS UM-2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT (URINARY TRACT)". The FDA issued a decision of Substantially Equivalent on November 16, 1998. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Olympus Optical, Co. has at least 10 other 510(k) clearances on record.