Cleared Special

SYNGO DYNAMICS VERSION 7.0 (K081018) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K081018 · Siemens Medical Solutions · Radiology device
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Apr 2008
Decision
15d
Days
Class 2
Risk

K081018 is an FDA 510(k) clearance for the SYNGO DYNAMICS VERSION 7.0. 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 Medical Solutions (Ann Arbor, US). The FDA issued a Cleared decision on April 25, 2008 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Incremental AI imaging tool. Low regulatory complexity profile. 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 Medical Solutions devices

Submission Details

510(k) Number K081018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2008
Decision Date April 25, 2008
Days to Decision 15 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Modification to existing cleared device. 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 Peers - LLZ System, Image Processing, Radiological

All 788
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K081018.
4D VIEWER RADIOLOGY, MODEL USWP-100A
K082684 · Toshiba America Medical Systems, In.C · Oct 2008
ULTRAEXTEND USWS-900A
K082596 · Toshiba America Medical Systems, In.C · Sep 2008
QUANTRA
K082483 · Hologic, Inc. · Sep 2008
DIGITAL LIGHTBOX
K080608 · Brainlab AG · Apr 2008
XIDF-100A/B1 IMAGE PROCESSOR
K073259 · Toshiba America Medical Systems, In.C · Dec 2007
INTEGRADWEB PACS SYSTEM
K072986 · Ge Healthcare · Nov 2007