510(k) K251268

Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) by Edan Instruments, Inc. — Product Code IYN

K251268 is an FDA 510(k) premarket notification submitted by Edan Instruments, Inc. for the device "Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)". The FDA issued a decision of Substantially Equivalent on December 23, 2025. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Edan Instruments, Inc. has at least 10 other 510(k) clearances on record.