Cleared Traditional

K253221 - Liver fat ultrasound quantitative system

K253221 is an FDA 510(k) clearance for Liver fat ultrasound quantitative system, manufactured by Eieling Technology (Shenzhen) Limited. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K253221 · Eieling Technology (Shenzhen) Limited · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2026
Decision
130d
Days
Class 2
Risk

K253221 is an FDA 510(k) clearance for the Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro). 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 February 6, 2026 after a review of 130 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 (Shenzhen) Limited devices

FDA 510(k) Submission Details - K253221

510(k) Number K253221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2025
Decision Date February 06, 2026
Days to Decision 130 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
23d slower than avg
Panel avg: 107d · This submission: 130d
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
Chen Salon

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 448
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K253221.
Accuro XV
K254021 · Rivanna Medical, Inc. · Apr 2026
QT Scanner 2000 Model A
K253898 · QT Imaging Holdings, Inc. · Mar 2026
IntraSight Plus
K253714 · Philips Image Guided Therapy Corporation · Feb 2026
Astrasono A3Pro Bladder Scanner (A3Pro)
K250331 · Astrasono Technology Co., Ltd. · Sep 2025
Deepsight NeedleVue LC1 Ultrasound System
K250381 · DeepSight Technology, Inc. · Aug 2025
B-Scan
K243227 · Accutome, Inc. Doing Business AS Keeler USA · Jul 2025