Cleared Traditional

K043194 - VOXAR 3D PRODUCT FAMILY

K043194 is an FDA 510(k) clearance for VOXAR 3D PRODUCT FAMILY, manufactured by Voxar Limited. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K043194 · Voxar Limited · Radiology device
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Jan 2005
Decision
54d
Days
Class 2
Risk

K043194 is an FDA 510(k) clearance for the VOXAR 3D PRODUCT FAMILY. 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 Voxar Limited (Edinburgh, Lothian, GB). The FDA issued a Cleared decision on January 11, 2005 after a review of 54 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 Voxar Limited devices

FDA 510(k) Submission Details - K043194

510(k) Number K043194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2004
Decision Date January 11, 2005
Days to Decision 54 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 107d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 1466
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K043194.
MONOCHROME LCD MONITOR, RADIFORCE G51
K042755 · Eizo Nanao Corporation · Feb 2005
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K043430 · Totoku Electric Co., Ltd. · Jan 2005
CENTRICITY PACS SYSTEM
K043415 · Ge Medical Systems Information Technologies · Jan 2005
MAMMOREPORT SOFTCOPY WORKSTATION
K042868 · Siemens Medical Solutions USA, Inc. · Jan 2005
VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM
K043333 · Vital Images, Inc. · Dec 2004
X-LEONARDO
K042995 · Siemens Medical Solutions USA, Inc. · Nov 2004