Cleared Traditional

GE MR MAX SYSTEM (K883547) - FDA 510(k) Clearance

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

K883547 · General Electric Co. · Radiology device
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Nov 1988
Decision
103d
Days
Class 2
Risk

K883547 is an FDA 510(k) clearance for the GE MR MAX SYSTEM. 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 November 30, 1988 after a review of 103 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 General Electric Co. devices

Submission Details

510(k) Number K883547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1988
Decision Date November 30, 1988
Days to Decision 103 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 107d · This submission: 103d
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 K883547.
VISTA MR 2055 HP SYSTEM
K885047 · Philips Medical Systems (Cleveland), Inc. · Mar 1989
MAGNETOM 42 SP AND MAGNETOM 63 SP
K883898 · Siemens Medical Solutions USA, Inc. · Jan 1989
MAGNETIC RESONANCE DIAGNOSTIC HELMHOLTZ NECK COIL
K884484 · Siemens Medical Solutions USA, Inc. · Jan 1989
POSTERIOR CERVICAL SPINE SURFACE COIL M1085AM
K884369 · General Electric Co. · Nov 1988
MAGNETOM (M, H, 42, 63) SEQUENCES
K884062 · Siemens Medical Solutions USA, Inc. · Nov 1988
CP HEAD COIL & 260MM (CV) TRANSMIT-RECEIVE COIL
K883872 · Siemens Medical Solutions USA, Inc. · Nov 1988