Cleared Traditional

K982978 - MODEL 340GE-21C QUADRATURE BRAIN COIL

K982978 is the FDA 510(k) clearance for MODEL 340GE-21C QUADRATURE BRAIN COIL by Medical Advances, Inc.. It is a Class 2 Radiology device (product code MOS) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K982978 · Medical Advances, Inc. · Radiology device
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Nov 1998
Decision
90d
Days
Class 2
Risk

K982978 is an FDA 510(k) clearance for the MODEL 340GE-21C QUADRATURE BRAIN COIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Medical Advances, Inc. (Milwaukee, US). The FDA issued a Cleared decision on November 23, 1998 after a review of 90 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 Medical Advances, Inc. devices

Submission Details

510(k) Number K982978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1998
Decision Date November 23, 1998
Days to Decision 90 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
17d faster than avg
Panel avg: 107d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 311
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K982978.
MEDRAD QUADRATURE CTL ARRAY COIL
K984159 · Medrad, Inc. · Jan 1999
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MAGNETIC RESONANCE DIAGNOSTIC DEVICE, AIRIS II
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SIGNA PROFILE SMALL HEAD COIL
K982972 · GE Medical Systems · Nov 1998
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