Cleared Traditional

MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY (K954353) - FDA 510(k) Clearance

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

K954353 · General Electric Co. · Radiology device
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Optimized for regulatory review, auditing and printing
Apr 1996
Decision
207d
Days
Class 2
Risk

K954353 is an FDA 510(k) clearance for the MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by General Electric Co. (Milwaukee, US). The FDA issued a Cleared decision on April 12, 1996 after a review of 207 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 General Electric Co. devices

Submission Details

510(k) Number K954353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1995
Decision Date April 12, 1996
Days to Decision 207 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
100d slower than avg
Panel avg: 107d · This submission: 207d
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 430
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K954353.
MR GUIDED PROCEDURES PACKAGE/MAGNETOM OPEN SYSTEM
K955389 · Siemens Medical Solutions USA, Inc. · Jun 1996
MOVABLE ADD-ON COUCH FOR OUTLOOK
K960973 · Philips Medical Systems (Cleveland), Inc. · May 1996
PHASE CONJUGATE SYMMETRY OPTION FOR OUTLOOK
K960294 · Philips Medical Systems (Cleveland), Inc. · Apr 1996
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K954354 · General Electric Co. · Apr 1996
AUXILIARY PATIENT TABLE/MAGNETOM OPEN SYSTEM
K955811 · Siemens Medical Solutions USA, Inc. · Mar 1996
EPI-II SYSTEM OPTION W/HIGH PERFORMANCE GRADIENTS
K954646 · Philips Medical Systems (Cleveland), Inc. · Jan 1996