K253221
- 510(k) number
- K253221
- Device name
- Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)
- Applicant
- Eieling Technology (Shenzhen) Limited CN
- Product code
- IYO — System, Imaging, Pulsed Echo, Ultrasonic
- Decision date
- 2026-02-06
- Date received
- 2025-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K253221.pdf
Official FDA record: K253221
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.