FDA 510(k)

Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)

K-Number: K242496 · 2024-11-19

ApplicantEieling Technology (Shenzhen) Limited

Decision Date2024-11-19

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) is a medical device manufactured by Eieling Technology (Shenzhen) Limited. It received FDA 510(k) clearance on 2024-11-19 under approval number K242496. 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 C)?

Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) is a medical device that received FDA 510(k) clearance on 2024-11-19. It is manufactured by Eieling Technology (Shenzhen) Limited. The 510(k) number is K242496.

When was Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) approved by the FDA?

Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) received FDA 510(k) clearance on 2024-11-19, under approval number K242496.

What company makes Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)?

Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) is manufactured by Eieling Technology (Shenzhen) Limited.

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

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

Related Clinical Trials

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Related PubMed Literature

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Other Devices by Eieling Technology (Shenzhen) Limited

K253221Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)

Related Devices (Code: IYO)

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Official Source

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