Cleared Traditional

K011582 - QCU ANALYTICAL SOFTWARE PACKAGE (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K011582 · Medis Medical Imaging Systems BV · Radiology device
Jul 2001
Decision
69d
Days
Class 2
Risk

K011582 is an FDA 510(k) clearance for the QCU ANALYTICAL SOFTWARE PACKAGE. 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 Medis Medical Imaging Systems BV (Leiden, NL). The FDA issued a Cleared decision on July 31, 2001 after a review of 69 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.

Submission Details

510(k) Number K011582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2001
Decision Date July 31, 2001
Days to Decision 69 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 127d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 125
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