Cleared Traditional

SYNGO IMAGING (VERSION V31) (K081734) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K081734 · Siemens AG Medical Solutions · Radiology device
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Jul 2008
Decision
14d
Days
Class 2
Risk

K081734 is an FDA 510(k) clearance for the SYNGO IMAGING (VERSION V31). 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 3, 2008 after a review of 14 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 K081734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2008
Decision Date July 03, 2008
Days to Decision 14 days
Submission Type Traditional
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
93d faster than avg
Panel avg: 107d · This submission: 14d
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 Peers - LLZ System, Image Processing, Radiological

All 757
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K081734.
SYNGOCIRCULATION DYNAMICPET, VERSION 1.0
K083327 · Siemens Medical Solutions USA, Inc. · May 2009
SYNGO US WORKPLACE
K091286 · Siemens Medical Solutions USA, Inc. · May 2009
ARTERIAL HEALTH PACKAGE (AHP) SOFTWARE
K083149 · Siemens Medical Solutions USA, Inc. · Jan 2009
INTEGRADWEB PACS SYSTEM
K072986 · Ge Healthcare · Nov 2007
GE ECHOPAC
K072952 · General Electric Co. · Nov 2007
SYNGO TRUED
K071950 · Siemens Medical Solutions USA, Inc. · Jul 2007