Cleared Traditional

SYNGO IMAGING (VERSION V30) (K071114) - FDA 510(k) Clearance

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

K071114 · Siemens AG Medical Solutions · Radiology device
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May 2007
Decision
32d
Days
Class 2
Risk

K071114 is an FDA 510(k) clearance for the SYNGO IMAGING (VERSION V30). 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 May 22, 2007 after a review of 32 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.

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Submission Details

510(k) Number K071114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2007
Decision Date May 22, 2007
Days to Decision 32 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
75d faster than avg
Panel avg: 107d · This submission: 32d
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 K071114.
INTEGRADWEB PACS SYSTEM
K072986 · Ge Healthcare · Nov 2007
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K072952 · General Electric Co. · Nov 2007
SYNGO TRUED
K071950 · Siemens Medical Solutions USA, Inc. · Jul 2007
SYNGO DYNAMICS, VERSION 6.0
K070322 · Siemens Medical Solutions USA, Inc. · Feb 2007
SYNGO MI APPLICATIONS 2007A
K063826 · Siemens Medical Solutions USA, Inc. · Jan 2007
GE LOGIQ WORKS
K063006 · General Electric Co. · Nov 2006