Cleared Special

K030953 - GE 3.0T GENERAL PURPOSE FLEX COIL

K030953 is an FDA 510(k) clearance for GE 3.0T GENERAL PURPOSE FLEX COIL, manufactured by Ge Medical Systems, Inc.. The device is a Class 2 Radiology device with product code MOS cleared through the Special 510(k) pathway after a 14-day FDA review.

K030953 · Ge Medical Systems, Inc. · Radiology device
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Apr 2003
Decision
14d
Days
Class 2
Risk

K030953 is an FDA 510(k) clearance for the GE 3.0T GENERAL PURPOSE FLEX COIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Ge Medical Systems, Inc. (Milwaukee, US). The FDA issued a Cleared decision on April 10, 2003 after a review of 14 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ge Medical Systems, Inc. devices

FDA 510(k) Submission Details - K030953

510(k) Number K030953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2003
Decision Date April 10, 2003
Days to Decision 14 days
Submission Type Special
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
93d faster than avg
Panel avg: 107d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

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 K030953.
MODIFICATION TO PREMIER III PHASED ARRAY CTL SPINE COIL
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K031089 · W.L. Gore & Associates, Inc. · May 2003
PRIMA III TOTALSENSE TORSO COIL
K030371 · Usa Instruments, Inc. · May 2003
3.0T TORSO PHASED ARRAY COIL
K030495 · Ge Medical Systems, Inc. · Mar 2003
PREMIER III PHASED ARRAY CTL SPINE COIL
K030042 · Usa Instruments, Inc. · Feb 2003
LEO III TX/RX QUADRATURE KNEE COIL
K023982 · Usa Instruments, Inc. · Feb 2003