Cleared Traditional

K151353 - syngo.MR Neurology, syngo.MR Oncology

K151353 is an FDA 510(k) clearance for syngo.MR Neurology, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K151353 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
79d
Days
Class 2
Risk

K151353 is an FDA 510(k) clearance for the syngo.MR Neurology, syngo.MR Oncology. 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 August 7, 2015 after a review of 79 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

FDA 510(k) Submission Details - K151353

510(k) Number K151353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2015
Decision Date August 07, 2015
Days to Decision 79 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
28d faster than avg
Panel avg: 107d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 1788
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K151353.
CS 3D Imaging
K151837 · Trophy · Aug 2015
Synapse Cardiovascular
K151859 · Fujifilm Medical Systems U.S.A, Inc. · Aug 2015
McKesson Cardiology
K151850 · Mckesson Israel , Ltd. · Aug 2015
QuantorView
K151687 · 3Disc Americas · Aug 2015
Arthrex OrthoVis Preoperative Plan
K151568 · Custom Orthopaedic Solutions, Inc. · Jul 2015
GenIQ
K143368 · Ge Medical Systems, LLC · Jul 2015