Cleared Traditional

K111142 - ECHOSOFT(TM)

K111142 is an FDA 510(k) clearance for ECHOSOFT(TM), manufactured by Echometrix, LLC. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 518-day FDA review.

K111142 · Echometrix, LLC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
518d
Days
Class 2
Risk

K111142 is an FDA 510(k) clearance for the ECHOSOFT(TM). Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Echometrix, LLC (Waukesha, US). The FDA issued a Cleared decision on September 21, 2012 after a review of 518 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Moderate-to-high equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Echometrix, LLC devices

FDA 510(k) Submission Details - K111142

510(k) Number K111142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2011
Decision Date September 21, 2012
Days to Decision 518 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
411d slower than avg
Panel avg: 107d · This submission: 518d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 - LLZ System, Image Processing, Radiological

All 1270
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K111142.
IMAGE-COM 5.0
K122289 · Tomtec Imaging Systems GmbH · Oct 2012
CARESTREAM VUE PACS
K122523 · Carestream Health, Inc. · Oct 2012
ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE
K121076 · Toshiba America Medical Systems, In.C · Oct 2012
ORTHOCAD SOFTWARE OPTION
K120288 · Esaote, S.P.A. · Sep 2012
VITREAVIEW
K122136 · Vital Images, Inc. · Sep 2012
MR VESSELLQ XPRESS
K122164 · GE Medical Systems SCS · Sep 2012