Cleared Traditional

Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) (K242496) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K242496 · Eieling Technology (Shenzhen) Limited · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2024
Decision
89d
Days
Class 2
Risk

K242496 is an FDA 510(k) clearance for the Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C). Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Eieling Technology (Shenzhen) Limited (Shenzhen, CN). The FDA issued a Cleared decision on November 19, 2024 after a review of 89 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Eieling Technology (Shenzhen) Limited devices

Submission Details

510(k) Number K242496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2024
Decision Date November 19, 2024
Days to Decision 89 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
18d faster than avg
Panel avg: 107d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 212
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K242496.
Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100)
K243880 · Wuxi Hisky Medical Technologies Co., Ltd. · Jun 2025
Accuro 3S
K243937 · Rivanna Medical, Inc. · May 2025
EchoGuide (Version 1)
K243479 · Sonavex, Inc. · Apr 2025
SpineUs™ System
K241029 · Verdure Imaging · Oct 2024
Velacur
K233977 · Sonic Incytes · Sep 2024
SC1 Handheld Ultrasound Imaging system (Model: SC1)
K233579 · Fcu Co., Ltd. · Jun 2024