Cleared Traditional

K061964 - SYNGO MULTIMODALITY WORKPLACE

K061964 is the FDA 510(k) clearance for SYNGO MULTIMODALITY WORKPLACE by Siemens AG Medical Solutions. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K061964 · Siemens AG Medical Solutions · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
15d
Days
Class 2
Risk

K061964 is an FDA 510(k) clearance for the SYNGO MULTIMODALITY WORKPLACE. 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 (Erlangen, DE). The FDA issued a Cleared decision on July 27, 2006 after a review of 15 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 K061964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2006
Decision Date July 27, 2006
Days to Decision 15 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
92d faster than avg
Panel avg: 107d · This submission: 15d
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 1130
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K061964.
SECURVIEW DX DIAGNOSTIC WORKSTATION, MODELS SV-0001, SV-0002 AND SV-0003
K062107 · Hologic, Inc. · Aug 2006
VITAL CONNECT 4.0
K062154 · Vital Images, Inc. · Aug 2006
MONOCHROME LCD MONITOR, RADIFORCE, GS320
K062053 · Eizo Nanao Corporation · Aug 2006
5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2116A (ME551I2)
K061447 · Totoku Electric Co., Ltd. · Jul 2006
SYNAPSE MIP/MPR IMAGE VISUALIZATION SOFTWARE OBLIQUUS
K061672 · Fujifilm Medical Systems U.S.A, Inc. · Jun 2006
VITREA, VERSION 3.9
K061624 · Vital Images, Inc. · Jun 2006