Cleared Traditional

K123420 - SYNGO

K123420 is the FDA 510(k) clearance for SYNGO by Siemens Medical Solutions USA, Inc.. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K123420 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
87d
Days
Class 2
Risk

K123420 is an FDA 510(k) clearance for the SYNGO, BREAST CARE. 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 USA, Inc. (Mavern, US). The FDA issued a Cleared decision on February 1, 2013 after a review of 87 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 Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K123420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2012
Decision Date February 01, 2013
Days to Decision 87 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 107d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 1092
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K123420.
VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNING
K122578 · Vital Images, Inc. · Feb 2013
4MP COLOR LCD MONITOR, RADIFORCE RX440
K130070 · Eizo Nanao Corporation · Feb 2013
CORONIS FUSION 6MP
K130103 · Barco N.V. · Feb 2013
SYNAPSE 3D COLON ANALYSIS
K123566 · Fujifilm Medical Systems U.S.A, Inc. · Jan 2013
SYNGO.VIA MI WORKFLOWS
K123577 · Siemens Medical Solutions USA, Inc. · Jan 2013
CARDIAC VX
K121762 · Ge Medical Systems, LLC · Jan 2013