Cleared Traditional

K233401 - Portable Liver Elastography Ultrasound ...

K233401 is an FDA 510(k) clearance for Portable Liver Elastography Ultrasound ..., manufactured by Eieling Technology Limited. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K233401 · Eieling Technology Limited · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2024
Decision
131d
Days
Class 2
Risk

K233401 is an FDA 510(k) clearance for the Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile). Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Eieling Technology Limited (Hong Kong, CN). The FDA issued a Cleared decision on February 12, 2024 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Eieling Technology Limited devices

FDA 510(k) Submission Details - K233401

510(k) Number K233401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2023
Decision Date February 12, 2024
Days to Decision 131 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 107d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Imd Medical & Drug Technology Service Institutions
Salon Chen

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 468
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K233401.
Pocket III
K232302 · Quantel Medical · Apr 2024
EdgeFlow UH10
K231677 · Edgecare, Inc. · Mar 2024
BD Prevue™ II Peripheral Vascular Access System
K240146 · Bard Access Systems, Inc. · Feb 2024
Bladder Scanner
K230986 · Avantsonic Technology Co., Ltd. · Dec 2023
Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS)
K231889 · Ultrasound Biotechnology (Shanghai) Co., Ltd. · Dec 2023
iSR`obot Mona Lisa 2.0
K232320 · Biobot Surgical Pte., Ltd. · Dec 2023