Cleared Traditional

K094064 - ILUMA VISION MODEL VERSION 2.2

K094064 is an FDA 510(k) clearance for ILUMA VISION MODEL VERSION 2.2, manufactured by 3M Imtec. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K094064 · 3M Imtec · Radiology device
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Apr 2010
Decision
120d
Days
Class 2
Risk

K094064 is an FDA 510(k) clearance for the ILUMA VISION MODEL VERSION 2.2. 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 3M Imtec (St. Paul, US). The FDA issued a Cleared decision on April 30, 2010 after a review of 120 days - within the typical 510(k) review window.

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 3M Imtec devices

FDA 510(k) Submission Details - K094064

510(k) Number K094064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2009
Decision Date April 30, 2010
Days to Decision 120 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
13d slower than avg
Panel avg: 107d · This submission: 120d
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 1315
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K094064.
SYNAPSE 3D BASIC TOOLS
K101662 · Fujifilm Medical System U.S.A., Inc. · Jul 2010
CORONIS FUSION 10MP, MODEL MDCG-10130
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SYMBIA.NET, SYMBIA.NET SELECT MODEL 10520828, 10520827
K100619 · Siemens Medical Solutions USA, Inc. · May 2010
CAAS QVA 3D, CAAS QCA 3D
K100292 · Pie Medical Imaging BV · Apr 2010
SYNAPSE OBLIQUUS MIP/MPR/FUSION
K100881 · Fujifilm Medical System U.S.A., Inc. · Apr 2010
STORM-BASE 2.0
K093603 · KARL STORZ Endoscopy-America, Inc. · Mar 2010