Cleared Abbreviated

ELLEX INNOVATIVE IMAGING EYE CUBED V4 (K083061) - FDA 510(k) Clearance

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

K083061 · Ellex, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
87d
Days
Class 2
Risk

K083061 is an FDA 510(k) clearance for the ELLEX INNOVATIVE IMAGING EYE CUBED V4. 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 January 9, 2009 after a review of 87 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Ellex, Inc. devices

Submission Details

510(k) Number K083061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2008
Decision Date January 09, 2009
Days to Decision 87 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 107d · This submission: 87d
Pathway characteristics
Standards-based clearance path.

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 181
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K083061.
SC2000 and ACUSON X300 Diagnostic Ultrasound Systems
K142395 · Siemens Medical Solutions USA, Inc. · Sep 2014
ILAB ULTRASOUND IMAGING SYSTEM
K130243 · Boston Scientific Corp · Mar 2013
ILAB ULTRASOUND IMAGING SYSTEM
K123535 · Boston Scientific Corp · Jan 2013
ACUSON X300 ULTRASOUND SYSTEM
K072676 · Siemens Medical Solutions USA, Inc. · Dec 2007
GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND
K072797 · General Electric Co. · Oct 2007
ILAB ULTRASOUND IMAGING SYSTEM, VERSION 1.3
K072517 · Boston Scientific Corp · Sep 2007