Cleared Traditional

K033831 - SIENET COSMOS

K033831 is the FDA 510(k) clearance for SIENET COSMOS by Siemens AG Medical Solutions. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K033831 · Siemens AG Medical Solutions · Radiology device
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Dec 2003
Decision
9d
Days
Class 2
Risk

K033831 is an FDA 510(k) clearance for the SIENET COSMOS. 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 Siemens AG Medical Solutions (Eriangen, DE). The FDA issued a Cleared decision on December 19, 2003 after a review of 9 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 Siemens AG Medical Solutions devices

Submission Details

510(k) Number K033831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2003
Decision Date December 19, 2003
Days to Decision 9 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 107d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Tuv America, Inc.
STEFAN PREISS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 1127
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K033831.
VITREA2 VERSION 3.5
K040305 · Vital Images, Inc. · Feb 2004
COLOR LCD DISPLAY, MODEL RADIFORCE R22
K033466 · Eizo Nanao Corporation · Feb 2004
ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE
K040142 · Adac Laboratories · Feb 2004
PACS SOFTWARE SOLUTION 2003
K033624 · Canon USA, Inc. · Dec 2003
CONSULTIVA CASE INPUT STATION, MODEL CIS-1
K031132 · Eastman Kodak Company · Nov 2003
VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE
K032748 · Vital Images, Inc. · Oct 2003