Cleared Traditional

K972990 - MAGNETIC RESONANCE DIAGNOSTIC SYSTEM

K972990 is an FDA 510(k) clearance for MAGNETIC RESONANCE DIAGNOSTIC SYSTEM, manufactured by GE Medical Systems. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K972990 · GE Medical Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
177d
Days
Class 2
Risk

K972990 is an FDA 510(k) clearance for the MAGNETIC RESONANCE DIAGNOSTIC SYSTEM. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by GE Medical Systems (Waukesha, US). The FDA issued a Cleared decision on February 5, 1998 after a review of 177 days - an extended review cycle.

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 devices

FDA 510(k) Submission Details - K972990

510(k) Number K972990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1997
Decision Date February 05, 1998
Days to Decision 177 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
70d slower than avg
Panel avg: 107d · This submission: 177d
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 840
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K972990.
STRATIS II
K974498 · Hitachi Medical Systems America, Inc. · Feb 1998
AIRIS II
K974212 · Hitachi Medical Systems America, Inc. · Feb 1998
DUFFUSION-WEIGHTED MR IMAGING PACKAGE
K974530 · Philips Medical Systems (Cleveland), Inc. · Feb 1998
CARDIAC TAGGING TECHNIQUES/MAGNETOM VISION AND MAGNETOM IMPACT
K973799 · Siemens Medical Solutions USA, Inc. · Jan 1998
KINEMATIC POSITIONERS
K972704 · Ge Medical Systems, Inc. · Sep 1997
ASSET APOLLO
K971884 · Philips Medical Systems (Cleveland), Inc. · Aug 1997