Cleared Traditional

K161397 - MAGiC

K161397 is the FDA 510(k) clearance for MAGiC by Ge Medical Systems, LLC. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K161397 · Ge Medical Systems, LLC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
104d
Days
Class 2
Risk

K161397 is an FDA 510(k) clearance for the MAGiC. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on August 31, 2016 after a review of 104 days - within the typical 510(k) review window.

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 Ge Medical Systems, LLC devices

Submission Details

510(k) Number K161397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2016
Decision Date August 31, 2016
Days to Decision 104 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
3d faster than avg
Panel avg: 107d · This submission: 104d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Radiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02596854 Completed Interventional Industry-sponsored

Comparative Study of Conventional 1.5 and 3.0T MR Images With Synthetically Reconstructed MR Images

117
Patients (actual)
6
Sites
Diagnostic
Purpose
Open label
Masking
Condition studied Clinical Indication for Brain MRI
Study design Single group
Eligibility All sexes · 18 Years+
Sponsor GE Healthcare (industry)
Started 2015-11-01 → Primary completion 2016-01-01 → Completed 2016-04-01
Primary outcome
Mean Diagnostic Image Quality Difference Between Conventional Versus Synthetic MR Utilizing a 5 Point Likert Scale
View full study on ClinicalTrials.gov

Regulatory Peers - LNH System, Nuclear Magnetic Resonance Imaging

All 817
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K161397.
HyperBand
K162403 · Ge Medical Systems, LLC · Nov 2016
G-scan Brio, S-scan
K161973 · Esaote, S.P.A. · Oct 2016
SIGNA Voyager
K161567 · Ge Healthcare · Sep 2016
Vantage Titan 1.5T, MRT-1510, V3.6 Software
K160632 · Toshibamedical Systems Corporation · Aug 2016
S-scan
K161238 · Esaote, S.P.A. · Jul 2016
Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T
K160618 · Ge Medical Systems, LLC · Jun 2016