Cleared Traditional

K982972 - SIGNA PROFILE SMALL HEAD COIL

K982972 is an FDA 510(k) clearance for SIGNA PROFILE SMALL HEAD COIL, manufactured by GE Medical Systems. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K982972 · GE Medical Systems · Radiology device
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Optimized for regulatory review, auditing and printing
Nov 1998
Decision
83d
Days
Class 2
Risk

K982972 is an FDA 510(k) clearance for the SIGNA PROFILE SMALL HEAD COIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on November 16, 1998 after a review of 83 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 devices

FDA 510(k) Submission Details - K982972

510(k) Number K982972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1998
Decision Date November 16, 1998
Days to Decision 83 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
24d faster than avg
Panel avg: 107d · This submission: 83d
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 K982972.
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL MRP-5000
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MODEL 340GE-21C QUADRATURE BRAIN COIL
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MARK 5000 PHASED ARRAY SHOULDER COIL
K983143 · Usa Instruments, Inc. · Nov 1998
MEDRAD 0.5T, 1.0T & 1.5T BREAST COIL, MODELS M21BRC, M42BRA, M64BRA
K982921 · Medrad, Inc. · Nov 1998
MEDRAD QUAD T/L COIL (1.5T, 1.0T & 0.5T) MODELS M64TLC, M42TLC, M21TLC
K982919 · Medrad, Inc. · Nov 1998