Cleared Traditional

K143290 - DBSWIN and VistaEasy Imaging Software

K143290 is an FDA 510(k) clearance for DBSWIN and VistaEasy Imaging Software, manufactured by Durr Dental AG. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 458-day FDA review.

K143290 · Durr Dental AG · Radiology device
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Feb 2016
Decision
458d
Days
Class 2
Risk

K143290 is an FDA 510(k) clearance for the DBSWIN and VistaEasy Imaging Software. 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 Durr Dental AG (Bietigheim-Bissingen, DE). The FDA issued a Cleared decision on February 18, 2016 after a review of 458 days - an unusually long review period, suggesting complex equivalence evaluation.

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-to-high 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 Durr Dental AG devices

FDA 510(k) Submission Details - K143290

510(k) Number K143290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2014
Decision Date February 18, 2016
Days to Decision 458 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
351d slower than avg
Panel avg: 107d · This submission: 458d
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 1236
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K143290.
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Synapse PACS
K160108 · Fujifilm Medical Systems U.S.A, Inc. · Feb 2016
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K152352 · GE Medical Systems SCS · Jan 2016