Cleared Traditional

GORE 3.0T TORSO ARRAY (K023679) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K023679 · W.L. Gore & Associates, Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
Nov 2002
Decision
17d
Days
Class 2
Risk

K023679 is an FDA 510(k) clearance for the GORE 3.0T TORSO ARRAY. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by W.L. Gore & Associates, Inc. (Newark, US). The FDA issued a Cleared decision on November 18, 2002 after a review of 17 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 W.L. Gore & Associates, Inc. devices

Submission Details

510(k) Number K023679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2002
Decision Date November 18, 2002
Days to Decision 17 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 107d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 Consultant

Tuv America, Inc.
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MOS Coil, Magnetic Resonance, Specialty

All 89
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K023679.
8 CHANNEL CARDIAC PHASED ARRAY COIL
K032045 · GE Medical Systems · Jul 2003
SENSE BODY COIL
K031095 · Philips Medical Systems (Cleveland), Inc. · Jun 2003
GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY
K031089 · W.L. Gore & Associates, Inc. · May 2003
EXTRA LARGE BODY COIL
K023442 · GE Medical Systems · Nov 2002
8 CHANNEL CARDIAC PHASED ARRAY COIL
K022669 · GE Medical Systems · Sep 2002
3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL
K003613 · GE Medical Systems · Apr 2001