Cleared Traditional

K033093 - ECHOCONNEX COMMUNICATOR

K033093 is an FDA 510(k) clearance for ECHOCONNEX COMMUNICATOR, manufactured by Connexmd. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K033093 · Connexmd · Radiology device
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Nov 2003
Decision
37d
Days
Class 2
Risk

K033093 is an FDA 510(k) clearance for the ECHOCONNEX COMMUNICATOR. 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 Connexmd (Seattle, US). The FDA issued a Cleared decision on November 5, 2003 after a review of 37 days - a notably fast clearance cycle.

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 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 Connexmd devices

FDA 510(k) Submission Details - K033093

510(k) Number K033093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2003
Decision Date November 05, 2003
Days to Decision 37 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
70d faster than avg
Panel avg: 107d · This submission: 37d
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 1584
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K033093.
SIENET COSMOS
K033831 · Siemens AG Medical Solutions · Dec 2003
PACS SOFTWARE SOLUTION 2003
K033624 · Canon USA, Inc. · Dec 2003
CONSULTIVA CASE INPUT STATION, MODEL CIS-1
K031132 · Eastman Kodak Company · Nov 2003
VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE
K032748 · Vital Images, Inc. · Oct 2003
HOLOGIC DR IMAGEPRO
K032546 · Hologic, Inc. · Oct 2003
WIDE 2MP TFT LCD MONITOR SYSTEM IF 1902A
K032960 · Wide Corporation · Oct 2003