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FDA 510(k)

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

K-Number: K253221 · 2026-02-06

ApplicantEieling Technology (Shenzhen) Limited
Decision Date2026-02-06
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) is a medical device manufactured by Eieling Technology (Shenzhen) Limited. It received FDA 510(k) clearance on 2026-02-06 under approval number K253221. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)?

Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) is a medical device that received FDA 510(k) clearance on 2026-02-06. It is manufactured by Eieling Technology (Shenzhen) Limited. The 510(k) number is K253221.

When was Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) approved by the FDA?

Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) received FDA 510(k) clearance on 2026-02-06, under approval number K253221.

What company makes Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)?

Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) is manufactured by Eieling Technology (Shenzhen) Limited.

What is the FDA product code for Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)?

The FDA product code for Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) is IYO.

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Other Devices by Eieling Technology (Shenzhen) Limited

K242496Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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