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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 the device name listed in this FDA 510(k) record. The listed applicant is Eieling Technology (Shenzhen) Limited. It received FDA 510(k) clearance on 2026-02-06 under 510(k) 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. The listed applicant is Eieling Technology (Shenzhen) Limited. The 510(k) number is K253221.

When did Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) receive FDA 510(k) clearance?

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

Who is the listed applicant for Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)?

The FDA 510(k) record lists Eieling Technology (Shenzhen) Limited as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07492862Multiparametric Ultrasound for the Noninvasive Diagnosis of Porto-sinusoidal Vascular Liver DisorderNOT_YET_RECRUITINGNCT07530419Samsung S-Viscosity vs Canon Dispersion Slope in Steatotic Liver Disease (SAVID-SLD)NOT_YET_RECRUITING

Other records listing Eieling Technology (Shenzhen) Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242496Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)

Related Devices (Code: IYO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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