Cleared Traditional

K033831 - SIENET COSMOS

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

K033831 · Siemens AG Medical Solutions · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K033831

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.

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 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 2293
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K033831.
ORTHOPACS
K033825 · Etrauma.Com Corp. · Feb 2004
CA-1500
K040028 · R2 Technology, Inc. · Jan 2004
MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1
K033712 · Sectra-Imtec AB · Dec 2003
PACS SOFTWARE SOLUTION 2003
K033624 · Canon USA, Inc. · Dec 2003
SENO ADVANTAGE
K033400 · Ge Medical Systems W-400 · Dec 2003
CONSULTIVA CASE INPUT STATION, MODEL CIS-1
K031132 · Eastman Kodak Company · Nov 2003
K033831 · SIENET COSMOS
Download PDF FDA Summary Siemens AG Medical So…