Cleared Traditional

K001946 - NEUROVASCULAR ARRAY COIL

K001946 is an FDA 510(k) clearance for NEUROVASCULAR ARRAY COIL, manufactured by Ge Medical Systems, Inc.. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K001946 · Ge Medical Systems, Inc. · Radiology device
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Aug 2000
Decision
65d
Days
Class 2
Risk

K001946 is an FDA 510(k) clearance for the NEUROVASCULAR ARRAY 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 August 30, 2000 after a review of 65 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, Inc. devices

FDA 510(k) Submission Details - K001946

510(k) Number K001946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2000
Decision Date August 30, 2000
Days to Decision 65 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
42d faster than avg
Panel avg: 107d · This submission: 65d
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 K001946.
OPART, MODEL MRT-600
K002522 · Toshiba America Mri, Inc. · Oct 2000
VISION 9000 PHASED ARRAY TORSO COIL
K002482 · Usa Instruments, Inc. · Oct 2000
OBC-63 MEBREAST ARRAY COIL
K002602 · Mri Devices Corp. · Sep 2000
OBC-096 BREAST ARRAY COIL
K002539 · Mri Devices Corp. · Aug 2000
MILLENNIUM 9000 PHASED ARRAY NEUROVASCULAR COIL
K001870 · Usa Instruments, Inc. · Aug 2000
HAC-300 HEAD ARRAY COIL
K001944 · Mri Devices Corp. · Aug 2000