Cleared Traditional

K101492 - 8 CHANNEL CARDIAC PHASED ARRAY COIL

K101492 is the FDA 510(k) clearance for 8 CHANNEL CARDIAC PHASED ARRAY COIL by Ge Healthcare Coils (Usa Instruments, Inc.). It is a Class 2 Radiology device (product code MOS) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K101492 · Ge Healthcare Coils (Usa Instruments, Inc.) · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
22d
Days
Class 2
Risk

K101492 is an FDA 510(k) clearance for the 8 CHANNEL CARDIAC PHASED ARRAY COIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Ge Healthcare Coils (Usa Instruments, Inc.) (Aurora, US). The FDA issued a Cleared decision on June 23, 2010 after a review of 22 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 Healthcare Coils (Usa Instruments, Inc.) devices

Submission Details

510(k) Number K101492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2010
Decision Date June 23, 2010
Days to Decision 22 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 107d · This submission: 22d
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 Peers - MOS Coil, Magnetic Resonance, Specialty

All 299
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K101492.
SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMS
K103275 · Siemens Medical Solutions USA, Inc. · Jan 2011
HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON
K102889 · Hitachi Medical Systems America, Inc. · Dec 2010
14-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZA
K100141 · Siemens Medical Solutions USA, Inc. · Aug 2010
S-SCAN, MODEL 9800020010
K100670 · Esaote, S.P.A. · Apr 2010
SPECIALTY COILS FOR THE MAGNETOM ESSENZA
K083166 · Siemens Medical Solutions USA, Inc. · Jan 2009
ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150)
K083086 · Hitachi Medical Systems America, Inc. · Dec 2008