Cleared Traditional

K020140 - VOXAR'S CALCIUM SCORING PRODUCT

K020140 is an FDA 510(k) clearance for VOXAR'S CALCIUM SCORING PRODUCT, 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 12-day FDA review.

K020140 · Voxar Limited · Radiology device
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Jan 2002
Decision
12d
Days
Class 2
Risk

K020140 is an FDA 510(k) clearance for the VOXAR'S CALCIUM SCORING PRODUCT. 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 28, 2002 after a review of 12 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.

FDA 510(k) Submission Details - K020140

510(k) Number K020140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2002
Decision Date January 28, 2002
Days to Decision 12 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 107d · This submission: 12d
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 Consultant

Underwriters Laboratories, Inc.
JEFF D RONGERO

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 2285
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K020140.
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K013922 · Barco N.V. · Jan 2002
3DFIS, MODEL IES-FL-101
K013841 · 3Dsharp, Inc. · Jan 2002
ACCENT
K013574 · Confirma, Inc. · Jan 2002
ENTEGRA PE PERSONAL DIGITAL ASSISTANT
K014058 · General Electric Medical Systems · Dec 2001
K020140 · VOXAR'S CALCIUM SCORING PRODUCT
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