Cleared Traditional

K003613 - 3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL

K003613 is an FDA 510(k) clearance for 3.0.T SIGNA VH/I (T/R) BODY IMAGING 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 132-day FDA review.

K003613 · GE Medical Systems · Radiology device
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Apr 2001
Decision
132d
Days
Class 2
Risk

K003613 is an FDA 510(k) clearance for the 3.0.T SIGNA VH/I (T/R) BODY IMAGING 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 April 3, 2001 after a review of 132 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.

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FDA 510(k) Submission Details - K003613

510(k) Number K003613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2000
Decision Date April 03, 2001
Days to Decision 132 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
25d slower than avg
Panel avg: 107d · This submission: 132d
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 K003613.
MARK 9000 PHASED ARRAY SHOULDER COIL
K010946 · Usa Instruments, Inc. · May 2001
KFA-127 KNEE, FOOT AND ANKLE ARRAY
K003505 · Mri Devices Corp. · May 2001
MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL
K010730 · Usa Instruments, Inc. · May 2001
MODEL 455GE PHASED ARRAY WRIST COIL
K010074 · Medical Advances, Inc. · Apr 2001
SIGNA SP 0.5T ROTATING HORIZONTAL BODY COIL
K003946 · GE Medical Systems · Feb 2001
HRH-127 HEAD ARRAY COIL
K010140 · Mri Devices Corp. · Feb 2001