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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 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 2024-11-19 under 510(k) 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. The listed applicant is Eieling Technology (Shenzhen) Limited. The 510(k) number is K242496.

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

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

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

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 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

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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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.

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

Related Devices (Code: IYO)

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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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