Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)— 510(k) K253221
Substantially EquivalentEieling Technology (Shenzhen) Limited
FDA 510(k) clearance K253221 for Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro), Substantially Equivalent on 2026-02-06. Applicant: Eieling Technology (Shenzhen) Limited. Device class: 2.
Summary
Eieling Technology (Shenzhen)'s device is named "Liver fat ultrasound quantitative system, The FattaLab," with models FL-CC M1 and FL-CC M1_Pro. It's filed under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), and the record doesn't say how the two differ.
Class II, 21 CFR 892.1560. Radiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Eieling Technology (Shenzhen) filed from Shenzhen, China. Review took 130 calendar days (September 29, 2025 to February 6, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- Eieling Technology (Shenzhen) Limited
- Product code
- Product code IYO
- Device class
- Class 2
- Regulation
- 21 CFR 892.1560
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code IYO
view allMore clearances from Eieling Technology (Shenzhen) Limited
view allAdverse events under product code IYO
product code IYO- Malfunction
- 3,339
- Total
- 3,339
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.