Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)

About This 510(k) Submission

K251268 is an FDA 510(k) clearance for the Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP), a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on December 23, 2025, 243 days after receiving the submission on April 24, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.