Cleared Traditional

SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO (K121434) - FDA 510(k) Clearance

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

K121434 · Siemens Medi Cal Solutions, Inc. · Radiology device
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Nov 2012
Decision
175d
Days
Class 2
Risk

K121434 is an FDA 510(k) clearance for the SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Siemens Medi Cal Solutions, Inc. (Malvern, US). The FDA issued a Cleared decision on November 5, 2012 after a review of 175 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Medi Cal Solutions, Inc. devices

Submission Details

510(k) Number K121434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2012
Decision Date November 05, 2012
Days to Decision 175 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 107d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LNH System, Nuclear Magnetic Resonance Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
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 - LNH System, Nuclear Magnetic Resonance Imaging

All 431
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K121434.
MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT
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K123938 · Siemens Medical Solutions USA, Inc. · Feb 2013
MAGNETOM SPECTRA
K121160 · Siemens Medical Solutions USA, Inc. · Jul 2012
MAGNETOM AERA AND MAGNETOM SKYRA
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K101347 · Siemens Medical Solutions USA, Inc. · Oct 2010