Cleared Traditional

K931460 - VECTRA MOBILE MAGNETIC RESONANCE IMAGIN...

K931460 is the FDA 510(k) clearance for VECTRA MOBILE MAGNETIC RESONANCE IMAGIN... by General Electric Co.. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 346-day FDA review.

K931460 · General Electric Co. · Radiology device
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Mar 1994
Decision
346d
Days
Class 2
Risk

K931460 is an FDA 510(k) clearance for the VECTRA MOBILE MAGNETIC RESONANCE IMAGING 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 March 4, 1994 after a review of 346 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K931460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1993
Decision Date March 04, 1994
Days to Decision 346 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
239d slower than avg
Panel avg: 107d · This submission: 346d
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 817
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K931460.
PHASED ARRAY PELVIC COIL
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SMT-100X/H AND SMT-100X/X MAGNETIC RESONANCE IMAGING SYSTEM
K932244 · Shimadzu Medical Systems · Feb 1994
MRT-50GP
K933018 · Toshiba America Mri, Inc. · Feb 1994