Cleared Traditional

K883547 - GE MR MAX SYSTEM

K883547 is an FDA 510(k) clearance for GE MR MAX SYSTEM, manufactured by General Electric Co.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 103-day FDA review.

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

FDA 510(k) Submission Details - K883547

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.

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 968
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K883547.
MT/S (SOFTWARE RELEASE 3.1)
K884607 · Diasonics, Inc. · Dec 1988
MT/S (SPINE TRANSMIT COIL)
K884606 · Diasonics, Inc. · Dec 1988
TEMPOROMANDIBULAR JOINT COIL (TMJ)
K884743 · Diasonics, Inc. · Dec 1988
SHOULDER TRANSMIT AND RECEIVE COILS
K884603 · Diasonics, Inc. · Nov 1988
MT/S CARLSON SPINE COIL, PART # 100-50082500-01
K884604 · Diasonics, Inc. · Nov 1988
POSTERIOR CERVICAL SPINE SURFACE COIL M1085AM
K884369 · General Electric Co. · Nov 1988