Cleared Traditional

K162943 - SyMRI

K162943 is an FDA 510(k) clearance for SyMRI, manufactured by Syntheticmr AB. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 312-day FDA review.

K162943 · Syntheticmr AB · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K162943

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.

LNH Device Classification - Class 2, Special Controls

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 841
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K162943.
ECHELON OVAL V6.0A MRI System
K172110 · Hitachi Healthcare Americas Corporation · Jan 2018
MAGNETOM Amira
K173600 · Siemens Medical Solutions USA, Inc. · Dec 2017
MAGNETOM Terra
K170840 · Siemens Medical Solutions USA, Inc. · Oct 2017
Vantage Elan 1.5T, V4.0
K171597 · Toshibamedical Systems Corporation · Jul 2017
SIGNA Premier
K171128 · Ge Medical Systems, LLC · Jul 2017
MAGNETOM Vida
K170396 · Siemens Medical Solutions USA, Inc. · Jun 2017