Cleared Abbreviated

K083061 - ELLEX INNOVATIVE IMAGING EYE CUBED V4

K083061 is an FDA 510(k) clearance for ELLEX INNOVATIVE IMAGING EYE CUBED V4, manufactured by Ellex, Inc.. The device is a Class 2 Radiology device with product code IYO cleared through the Abbreviated 510(k) pathway after a 87-day FDA review.

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.

FDA 510(k) Submission Details - K083061

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 107d · This submission: 87d
Pathway characteristics
Standards-based clearance path.

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 Peers - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 849
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K083061.
SPEQ ULTRASOUND SYSTEM
K090505 · Signostics Pty, Ltd. · May 2009
IMAGO C21 DIAGNOSTIC ULTRASOUND SYSTEM
K090059 · Saset (Chengdu), Inc. · Apr 2009
VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND
K090214 · Verathon Incorporated · Mar 2009
SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER
K081148 · Siemens Medical Solutions USA, Inc., Ultrasound DI · Dec 2008
VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600
K082456 · Verathon Incorporated · Dec 2008
SONOCINE ADJUNCTIVE BREAST ULTRASOUND SYSTEM (ABU), MODEL 100
K082543 · Sonocine, Inc. · Oct 2008
K083061 · ELLEX INNOVATIVE IMAGING EYE CUBED V4
Download PDF Ellex, Inc.