Cleared Traditional

K042383 - RSA-CMS

K042383 is the FDA 510(k) clearance for RSA-CMS by Medis Medical Imaging Systems BV. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K042383 · Medis Medical Imaging Systems BV · Radiology device
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Oct 2004
Decision
49d
Days
Class 2
Risk

K042383 is an FDA 510(k) clearance for the RSA-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 October 20, 2004 after a review of 49 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 Medis Medical Imaging Systems BV devices

Submission Details

510(k) Number K042383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2004
Decision Date October 20, 2004
Days to Decision 49 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
58d faster than avg
Panel avg: 107d · This submission: 49d
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 1057
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K042383.
VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM
K043333 · Vital Images, Inc. · Dec 2004
X-LEONARDO
K042995 · Siemens Medical Solutions USA, Inc. · Nov 2004
PHILIPS ORTHOPAEDIC APPLICATIONS
K042867 · Philips Medical Systems North America, Inc. · Nov 2004
CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL HARDCOPY WORKSTATION
K042525 · Ge Medical Systems Information Technologies · Oct 2004
LEONARDO SYNGO CARDIOLOGY WORKSTATION
K042203 · Siemens Medical Solutions USA, Inc. · Sep 2004
SECURVIEW DX SOFTCOPY WORKSTATION
K041555 · Hologic, Inc. · Aug 2004