Eieling Technology (Shenzhen) Limited · Class II · Cleared Feb 6, 2026
| K-number | K253221 |
| Device name | Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) |
| Applicant | Eieling Technology (Shenzhen) Limited |
| Product code | IYO |
| Device class | Class II |
| Decision date | Feb 6, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 892.1560 |
The FattaLab is a liver fat ultrasound quantitative system that provides B-mode imaging and measures ultrasound attenuation coefficient (MAP: Mobile Attenuation Parameter) of liver tissue at 3.5MHz in adult patients. The MAP measurement is used as an aid to diagnosis and monitoring of liver disease as part of an overall liver assessment. The device is intended for use by qualified healthcare professionals in hospitals and clinics for non-invasive liver assessment in a painless manner.
The proposed device removes the transient elastography (TE) mode and liver stiffness measurement capabilities present in the predicate device (Liverscan Mobile), providing only MAP measurement for liver fat quantification. Both devices use piezoelectric ultrasound sources at 3.5MHz with similar transducers and probe depths (25-65/35-75/45-85mm). The proposed device comes in two models (FL-CC M1 and FL-CC M1_Pro) with smaller form factors and lower weight than the predicate. Both comply with the same electrical safety, EMC, usability, software, and performance standards.
IEC 60601-1:2005+A1:2012+A2:2020 (electrical safety), IEC 60601-1-2:2014/AMD1:2020 (EMC), IEC 60601-2-37:2015 (ultrasonic equipment performance), IEC 62359:2017 (thermal and mechanical indices), IEC 61161:2013 (ultrasonic power measurement), IEC 60601-1-6:2010+A1:2013+A2:2020 (usability), IEC 62366-1:2015 (usability engineering), IEC 62304 (software validation), ISO 10993-1 (biocompatibility), and FDA guidance on software premarket submissions.
The FattaLab is substantially equivalent because its MAP measurement function is identical to the predicate device's MAP function in working principle and performance indicators, and the removal of TE mode does not affect safety or effectiveness for the narrower intended use of liver fat quantification alone. Both devices use the same basic ultrasound technology, comply with identical safety and performance standards, and are indicated for non-invasive liver assessment in adult patients. Bench testing confirmed the proposed device meets all design specifications and acceptance criteria.
View the full FDA submission: accessdata.fda.gov