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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 a medical device manufactured by Eieling Technology Limited. It received FDA 510(k) clearance on 2024-02-12 under approval 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. It is manufactured by Eieling Technology Limited. The 510(k) number is K233401.

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

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

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

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

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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Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025) PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025)

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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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