Cleared Traditional

SyMRI (K162943) - FDA 510(k) Clearance

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

K162943 · Syntheticmr AB · Radiology device
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Aug 2017
Decision
312d
Days
Class 2
Risk

K162943 is an FDA 510(k) clearance for the SyMRI. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Syntheticmr AB (Linkoping, SE). The FDA issued a Cleared decision on August 29, 2017 after a review of 312 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Syntheticmr AB devices

Submission Details

510(k) Number K162943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2016
Decision Date August 29, 2017
Days to Decision 312 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
205d slower than avg
Panel avg: 107d · This submission: 312d
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 499
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K162943.
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SIGNA Premier
K171128 · Ge Medical Systems, LLC · Jul 2017
MAGNETOM Vida
K170396 · Siemens Medical Solutions USA, Inc. · Jun 2017