Cleared Traditional

K101492 - 8 CHANNEL CARDIAC PHASED ARRAY COIL

K101492 is an FDA 510(k) clearance for 8 CHANNEL CARDIAC PHASED ARRAY COIL, manufactured by Ge Healthcare Coils (Usa Instruments, Inc.). The device is a Class 2 Radiology device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K101492

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.

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 490
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K101492.
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K101492 · 8 CHANNEL CARDIAC PHASED ARRAY COIL
Download PDF FDA Summary Ge Healthcare Coils (…