Cleared Traditional

K915542 - QCA PLUS

K915542 is an FDA 510(k) clearance for QCA 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 45-day FDA review.

K915542 · Sanders Data Systems, LLC · Radiology device
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Jan 1992
Decision
45d
Days
Class 2
Risk

K915542 is an FDA 510(k) clearance for the QCA 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 January 24, 1992 after a review of 45 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 - K915542

510(k) Number K915542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1991
Decision Date January 24, 1992
Days to Decision 45 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
62d faster than avg
Panel avg: 107d · This submission: 45d
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 1737
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K915542.
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PHILIPS PCR-ACE SYSTEM
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HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE
K913264 · Mallinckrodt Group, Inc. · Nov 1991
FUJI COMPUTED RADIOGRAPHY SYSTEM FCR 7501
K910437 · Fujifilm Medical System U.S.A., Inc. · Apr 1991