Cleared Traditional

Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)

K253221 · Eieling Technology (Shenzhen) Limited · Radiology

Feb 2026

Decision

130d

Days

Class 2

Risk

About This 510(k) Submission

K253221 is an FDA 510(k) clearance for the Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro), a System, Imaging, Pulsed Echo, Ultrasonic (Class II — Special Controls, product code IYO), submitted by Eieling Technology (Shenzhen) Limited (Shenzhen, CN). The FDA issued a Cleared decision on February 6, 2026, 130 days after receiving the submission on September 29, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number	K253221 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2025
Decision Date	February 06, 2026
Days to Decision	130 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF