Cleared Traditional

K040746 - MRA-CMS (FDA 510(k) Clearance)

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

K040746 · Medis Medical Imaging Systems BV · Radiology device
Jun 2004
Decision
77d
Days
Class 2
Risk

K040746 is an FDA 510(k) clearance for the MRA-CMS. 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 June 8, 2004 after a review of 77 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 K040746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2004
Decision Date June 08, 2004
Days to Decision 77 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 127d · This submission: 77d
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
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K040746.
ARTICOR planner
K252195 · Artiness S.R.L · Mar 2026
TheraSphere 360™ Y-90 Management Platform
K260479 · Boston Scientific Corporation · Mar 2026
Aeka Imaging
K253111 · Good Methods Global, Inc. · Mar 2026
Mimics Thoracic Planner
K251964 · Materialise NV · Mar 2026
SKIA-Head (Model: SKIA-ST00)
K253486 · Skia, Inc. · Feb 2026
AS Software Version Asera
K260205 · AS Software, LLC · Feb 2026