Cleared Traditional

DISCOVERY MR750W 3.0T (K130115) - FDA 510(k) Clearance

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

K130115 · Ge Medical Systems, LLC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
127d
Days
Class 2
Risk

K130115 is an FDA 510(k) clearance for the DISCOVERY MR750W 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 May 23, 2013 after a review of 127 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 K130115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2013
Decision Date May 23, 2013
Days to Decision 127 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
20d slower than avg
Panel avg: 107d · This submission: 127d
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 431
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K130115.
MAGNETOM PRISMA, MAGNETOM PRISMA FIT
K132119 · Siemens Medical Solutions USA, Inc. · Nov 2013
MAGNETOM AERA
K132951 · Siemens Medical Solutions USA, Inc. · Nov 2013
QUIET/SILENT SCANNING SUITE
K132831 · Siemens Medical Solutions USA, Inc. · Nov 2013
MAGNETOM SKYRA
K123510 · Siemens Medical Solutions USA, Inc. · May 2013
MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT
K130885 · Siemens Medical Solutions USA, Inc. · May 2013
MAGNETOM ESSENZA WITH SYNGO MR D14
K130262 · Siemens Medical Solutions USA, Inc. · Mar 2013