Cleared Traditional

K972296 - MAGNETIC RESONANCE DIAGNOSTIC SYSTEM

K972296 is an FDA 510(k) clearance for MAGNETIC RESONANCE DIAGNOSTIC SYSTEM, manufactured by Ge Medical Systems, Inc.. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K972296 · Ge Medical Systems, Inc. · Radiology device
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Sep 1997
Decision
88d
Days
Class 2
Risk

K972296 is an FDA 510(k) clearance for the MAGNETIC RESONANCE DIAGNOSTIC SYSTEM. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Ge Medical Systems, Inc. (Milwaukee, US). The FDA issued a Cleared decision on September 15, 1997 after a review of 88 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.

View all Ge Medical Systems, Inc. devices

FDA 510(k) Submission Details - K972296

510(k) Number K972296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1997
Decision Date September 15, 1997
Days to Decision 88 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
19d faster than avg
Panel avg: 107d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOS Device Classification - Class 2, Special Controls

Product Code MOS Coil, Magnetic Resonance, Specialty
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 - MOS Coil, Magnetic Resonance, Specialty

All 312
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K972296.
MEDRAD 1.5T PERIPHERAL VASCULAR ARRAY
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K973630 · Siemens Medical Solutions USA, Inc. · Dec 1997
2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)
K972592 · Elscint, Inc. · Sep 1997
ALPHA 7000 QUADRATURE WRIST COIL
K972205 · Usa Instruments, Inc. · Sep 1997
INSIGHT 7000 PHASED ARRAY TORSO COIL
K972340 · Usa Instruments, Inc. · Aug 1997