Cleared Traditional

K022789 - VIATRONIX V3D EXPLORER

K022789 is an FDA 510(k) clearance for VIATRONIX V3D EXPLORER, manufactured by Viatronix, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K022789 · Viatronix, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
15d
Days
Class 2
Risk

K022789 is an FDA 510(k) clearance for the VIATRONIX V3D EXPLORER. 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 Viatronix, Inc. (Research Triangel Park, US). The FDA issued a Cleared decision on September 6, 2002 after a review of 15 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 Viatronix, Inc. devices

FDA 510(k) Submission Details - K022789

510(k) Number K022789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2002
Decision Date September 06, 2002
Days to Decision 15 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 107d · This submission: 15d
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 1335
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K022789.
ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTS
K023100 · General Electric Medical Systems Information Techn · Oct 2002
CSV12 SOFTWARE VIEWER
K022896 · Acuson Corp. · Oct 2002
IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO
K022292 · Agfa Corp. · Sep 2002
FLAT PANEL DISPLAYS, ME SERIES & CCL SERIES
K021738 · Totoku Electric Co., Ltd. · Aug 2002
PATXFER
K021583 · Brainlab AG · Aug 2002
QUANTITATIVE BLOOD POOL SPECT (QBS)
K022428 · Adac Laboratories · Aug 2002