K253221 is an FDA 510(k) clearance for the Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro). This device is classified as 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 FDA review panel. Regulated under 21 CFR 892.1560.
| 510(k) Number | K253221 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | IYO - System, Imaging, Pulsed Echo, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1560 |