Cleared Traditional

K003946 - SIGNA SP 0.5T ROTATING HORIZONTAL BODY COIL

K003946 is an FDA 510(k) clearance for SIGNA SP 0.5T ROTATING HORIZONTAL BODY 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 68-day FDA review.

K003946 · GE Medical Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
68d
Days
Class 2
Risk

K003946 is an FDA 510(k) clearance for the SIGNA SP 0.5T ROTATING HORIZONTAL BODY 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 February 27, 2001 after a review of 68 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 - K003946

510(k) Number K003946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2000
Decision Date February 27, 2001
Days to Decision 68 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
39d faster than avg
Panel avg: 107d · This submission: 68d
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 K003946.
MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL
K010730 · Usa Instruments, Inc. · May 2001
3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL
K003613 · GE Medical Systems · Apr 2001
MODEL 455GE PHASED ARRAY WRIST COIL
K010074 · Medical Advances, Inc. · Apr 2001
HRH-127 HEAD ARRAY COIL
K010140 · Mri Devices Corp. · Feb 2001
PHS-63 PEDIATRIC HEAD AND SPINE ARRAY COIL
K003655 · Mri Devices Corp. · Feb 2001
MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL
K003685 · Medical Advances, Inc. · Dec 2000