Cleared Traditional

K982978 - MODEL 340GE-21C QUADRATURE BRAIN COIL

K982978 is an FDA 510(k) clearance for MODEL 340GE-21C QUADRATURE BRAIN COIL, manufactured by Medical Advances, Inc.. The device is a Class 2 Radiology device with 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

FDA 510(k) Submission Details - K982978

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.

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 453
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K982978.
MEDRAD QUADRATURE CTL ARRAY COIL
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SIGNA PROFILE SMALL HEAD COIL
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MARK 5000 PHASED ARRAY SHOULDER COIL
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MEDRAD 0.5T, 1.0T & 1.5T BREAST COIL, MODELS M21BRC, M42BRA, M64BRA
K982921 · Medrad, Inc. · Nov 1998