Cleared Traditional

K964141 - GE STERILE DISPOSABLE EQUIPMENT COIL COVER

K964141 is an FDA 510(k) clearance for GE STERILE DISPOSABLE EQUIPMENT COIL COVER, manufactured by Contour Fabricators, Inc.. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K964141 · Contour Fabricators, Inc. · Radiology device
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Jan 1997
Decision
107d
Days
Class 2
Risk

K964141 is an FDA 510(k) clearance for the GE STERILE DISPOSABLE EQUIPMENT COIL COVER. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Contour Fabricators, Inc. (Tarpon Springs, US). The FDA issued a Cleared decision on January 30, 1997 after a review of 107 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 Contour Fabricators, Inc. devices

FDA 510(k) Submission Details - K964141

510(k) Number K964141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1996
Decision Date January 30, 1997
Days to Decision 107 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
At panel average
Panel avg: 107d · This submission: 107d
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 446
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K964141.
MODELS EXL AND EXS EXTREMITY COIL SET
K964668 · Mri Devices Corp. · Feb 1997
PHASED ARRAY NECK COIL
K964678 · Philips Medical Systems (Cleveland), Inc. · Feb 1997
MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURGACE COIL
K964854 · Medrad, Inc. · Feb 1997
PHASED ARRAY SHOULDER COIL
K963356 · Philips Medical Systems (Cleveland), Inc. · Nov 1996
ARRAY OPEN BREAST COIL (MODEL OBC-63 PA)
K961525 · Mri Devices Corp. · Sep 1996
MINI FLEX COIL
K961628 · W.L. Gore & Associates, Inc. · Sep 1996