510(k) K253221

Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) by Eieling Technology (Shenzhen) Limited — Product Code IYO

K253221 is an FDA 510(k) premarket notification submitted by Eieling Technology (Shenzhen) Limited for the device "Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)". The FDA issued a decision of Substantially Equivalent on February 6, 2026. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Eieling Technology (Shenzhen) Limited has at least 1 other 510(k) clearance on record.