Cleared Special

K103608 - I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND (FDA 510(k) Clearance)

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K103608 · Ellex, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
18d
Days
Class 2
Risk

K103608 is an FDA 510(k) clearance for the I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Ellex, Inc. (Sacramento, US). The FDA issued a Cleared decision on December 27, 2010 after a review of 18 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ellex, Inc. devices

Submission Details

510(k) Number K103608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2010
Decision Date December 27, 2010
Days to Decision 18 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 107d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

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 Peers - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 891
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K103608.
EdgeFlow UW20
K252237 · Edgecare, Inc. · Apr 2026
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
Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)
K253221 · Eieling Technology (Shenzhen) Limited · Feb 2026
Astrasono A3Pro Bladder Scanner (A3Pro)
K250331 · Astrasono Technology Co., Ltd. · Sep 2025