Cleared Traditional

K123375 - SYNGO.VIA

K123375 is an FDA 510(k) clearance for SYNGO.VIA, manufactured by Siemens AG. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K123375 · Siemens AG · Radiology device
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Nov 2012
Decision
19d
Days
Class 2
Risk

K123375 is an FDA 510(k) clearance for the SYNGO.VIA. 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 (Erlangen, DE). The FDA issued a Cleared decision on November 20, 2012 after a review of 19 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 devices

FDA 510(k) Submission Details - K123375

510(k) Number K123375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2012
Decision Date November 20, 2012
Days to Decision 19 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
88d faster than avg
Panel avg: 107d · This submission: 19d
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 Peers - LLZ System, Image Processing, Radiological

All 1236
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K123375.
INTERVENTIONAL WORKSPOT
K121296 · Philips Medical Systems Nederland B.V. · Jan 2013
SCENIUM
K123528 · Siemens Medical Solutions USA, Inc. · Dec 2012
MAMMOGRAPHY PRIOR ENHANCEMENT (MPE)
K123530 · Hologic, Inc. · Dec 2012
CENTRICITY PACS-IW WITH UNIVERSAL VIEWER
K123174 · Ge Healthcare · Nov 2012
FLIGHTPLAN FOR LIVER
K121200 · Ge Healthcare · Nov 2012
VITREAADVANCED
K121213 · Vital Images, Inc. · Nov 2012