Cleared Traditional

K963859 - QLVA PLUS

K963859 is an FDA 510(k) clearance for QLVA PLUS, manufactured by Sanders Data Systems, LLC. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K963859 · Sanders Data Systems, LLC · Radiology device
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Dec 1996
Decision
83d
Days
Class 2
Risk

K963859 is an FDA 510(k) clearance for the QLVA PLUS. 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 Sanders Data Systems, LLC (Palo Alto, US). The FDA issued a Cleared decision on December 18, 1996 after a review of 83 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 Sanders Data Systems, LLC devices

FDA 510(k) Submission Details - K963859

510(k) Number K963859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1996
Decision Date December 18, 1996
Days to Decision 83 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 107d · This submission: 83d
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 1734
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K963859.
DIGITAL IMAGE ANALYSIS SYSTEM
K962153 · University of Washington · Jan 1997
IPU RX-2
K964327 · Medirex, Inc. · Jan 1997
PHILIPS EASYVISION
K963980 · Philips Medical Systems North America, Inc. · Dec 1996
PHILIPS COMPUTED RADIOGRAPHY
K964124 · Philips Medical Systems, Inc. · Dec 1996
AKI COMPACS DATA COMPRESION MODULE FOR DIAGNOSTIC IMAGES
K963610 · A.L.I. Technologies, Inc. · Nov 1996
ADVANCED DIAGNOSTIC VIEWER (ADV)
K963697 · Bio-Vascular, Inc. · Nov 1996