510(k) K253221 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)
| Applicant | Eieling Technology (Shenzhen) Limited, Shenzhen, CN |
| Decision | Substantially Equivalent, Feb 6, 2026 |
| Received | Sep 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253221
No recall in the FDA data names this 510(k).
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