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FDA 510(k)

Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)

K-Number: K233401 · 2024-02-12

ApplicantEieling Technology Limited
Decision Date2024-02-12
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) is the device name listed in this FDA 510(k) record. The listed applicant is Eieling Technology Limited. It received FDA 510(k) clearance on 2024-02-12 under 510(k) number K233401. 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 Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)?

Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) is a medical device that received FDA 510(k) clearance on 2024-02-12. The listed applicant is Eieling Technology Limited. The 510(k) number is K233401.

When did Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) receive FDA 510(k) clearance?

Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) received FDA 510(k) clearance on 2024-02-12, under 510(k) number K233401.

Who is the listed applicant for Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)?

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

What is the FDA product code for Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)?

The FDA product code for Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) is IYO.

Related Clinical Trials

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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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