# K253221: Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)

- Pathway: 510(k) (Traditional)
- Applicant: Eieling Technology (Shenzhen) Limited
- Decided: Feb 6, 2026 after 130 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 25 generations back to K935595 (1995). 164 ancestors in all.
No later device cites it as a predicate yet.
0 of 165 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233401: Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile), Eieling Technology Limited (2024) Summary page 5.

## Indications for use
The FattaLab provides B-mode imaging and is intended to measure ultrasound attenuation coefficient (MAP: Mobile Attenuation Parameter) of liver tissue for adult patients at 3.5MHz. The MAP may be used as an aid to diagnosis and monitoring of adult patients with liver disease, as part of an overall assessment of the liver. This device is intended for use by qualified and appropriately trained healthcare professionals in hospitals, clinics or any facility where healthcare is provided to measure the ultrasound attenuation coefficient of the liver in patients with liver disease. It does so in a painless and completely non-invasive manner. To ensure safe and effective operation, the operator shall meet the following requirements: 1) Receive training as required by local, state and national regulations, if applicable 2) Receive additional training as required by the authorized distributor or EIELING 3) Has a thorough knowledge and understanding of the material presented in the labeling

Source page: https://510kreport.com/device/K253221
Methodology: https://510kreport.com/methodology