Cleared Traditional

K163331 - Discovery MR750 3.0T

Also marketed or referenced as:
Discovery MR750w 3.0T Discovery MR450 1.5T Discovery MR450w 1.5T SIGNA Architect and SIGNA Artist

K163331 is the FDA 510(k) clearance for Discovery MR750 3.0T by Ge Medical Systems, LLC. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K163331 · Ge Medical Systems, LLC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
109d
Days
Class 2
Risk

K163331 is an FDA 510(k) clearance for the Discovery MR750 3.0T. 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 March 17, 2017 after a review of 109 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 K163331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2016
Decision Date March 17, 2017
Days to Decision 109 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
2d slower than avg
Panel avg: 107d · This submission: 109d
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 817
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K163331.
MAGNETOM Vida
K170396 · Siemens Medical Solutions USA, Inc. · Jun 2017
Vantage Titan 1.5T, MRT-1510, M-Power GX
K170412 · Toshibamedical Systems Corporation · Jun 2017
HyperSense
K162722 · Ge Medical Systems, LLC · Apr 2017
MAGNETOM Sempra with syngo MR E11S
K163211 · Siemens Medical Solutions USA, Inc. · Jan 2017
MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software
K163312 · Siemens Medical Solutions USA, Inc. · Jan 2017
Ingenia 1.5T CX and Ingenia 3.0T CX R5.3
K162931 · Philips Medical Systems Nederland B.V. · Jan 2017