Cleared Traditional

GE MR MAX SYSTEM (K895794) - FDA 510(k) Clearance

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

K895794 · GE Medical Systems · Radiology device
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Nov 1989
Decision
50d
Days
Class 2
Risk

K895794 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 GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on November 17, 1989 after a review of 50 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K895794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1989
Decision Date November 17, 1989
Days to Decision 50 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
57d faster than avg
Panel avg: 107d · This submission: 50d
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 498
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K895794.
VISTA MR 2055 HP SYSTEM
K896508 · Philips Medical Systems (Cleveland), Inc. · Jan 1990
GYROSCAN T5 MOBILE
K895869 · Philips Medical Systems, Inc. · Dec 1989
MAGNETOM M, H, 42, 63, 42 SP AND 63 SP
K895966 · Siemens Medical Solutions USA, Inc. · Nov 1989
VISTA MR 2055 HP SYSTEM
K895151 · Philips Medical Systems (Cleveland), Inc. · Oct 1989
ADD'L OPTIONS 1.5 TESLA & 1.0 TESLA TO MAGNETOM 42
K895221 · Siemens Medical Solutions USA, Inc. · Oct 1989
GE SIGNA ADVANTAGE
K893509 · GE Medical Systems · Aug 1989