Cleared Abbreviated

K223378 - 3.0T 16ch AIR AA

K223378 is the FDA 510(k) clearance for 3.0T 16ch AIR AA by Ge Healthcare Coils (Usa Instruments, Inc.). It is a Class 2 Radiology device (product code MOS) cleared through the Abbreviated 510(k) pathway after a 57-day FDA review.

K223378 · Ge Healthcare Coils (Usa Instruments, Inc.) · Radiology device
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Jan 2023
Decision
57d
Days
Class 2
Risk

K223378 is an FDA 510(k) clearance for the 3.0T 16ch AIR AA. 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 January 3, 2023 after a review of 57 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Ge Healthcare Coils (Usa Instruments, Inc.) devices

Submission Details

510(k) Number K223378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2022
Decision Date January 03, 2023
Days to Decision 57 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 107d · This submission: 57d
Pathway characteristics
Standards-based clearance path.

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 298
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