510(k) K924980

CATHSCANNER VISIONS MICRORAIL ULTRA IMAG CATH by Endosonics Corp. — Product Code ITX

K924980 is an FDA 510(k) premarket notification submitted by Endosonics Corp. for the device "CATHSCANNER VISIONS MICRORAIL ULTRA IMAG CATH". The FDA issued a decision of Substantially Equivalent on January 15, 1993. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Endosonics Corp. has at least 10 other 510(k) clearances on record.