Cleared Traditional

GE SIGNA ADVANTAGE (K893509) - FDA 510(k) Clearance

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

K893509 · GE Medical Systems · Radiology device
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Aug 1989
Decision
98d
Days
Class 2
Risk

K893509 is an FDA 510(k) clearance for the GE SIGNA ADVANTAGE. 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 August 11, 1989 after a review of 98 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 GE Medical Systems devices

Submission Details

510(k) Number K893509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1989
Decision Date August 11, 1989
Days to Decision 98 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
9d faster than avg
Panel avg: 107d · This submission: 98d
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 K893509.
GE MR MAX SYSTEM
K895794 · GE Medical Systems · Nov 1989
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ADD'L OPTIONS 1.5 TESLA & 1.0 TESLA TO MAGNETOM 42
K895221 · Siemens Medical Solutions USA, Inc. · Oct 1989
SOFTWARE VERSION, D1.3 AND A1.3 FOR MAGNETOM
K893640 · Siemens Medical Solutions USA, Inc. · Aug 1989
VISION INTEGRATED PERFORMANCE OPTION
K893689 · Siemens Medical Solutions USA, Inc. · Jul 1989
VISTA MR 2055 HP SYSTEM AND 2055 UPGRADES
K893675 · Philips Medical Systems (Cleveland), Inc. · Jul 1989