Cleared Abbreviated

3.0T AIR 32CH HNA

K253738 · Ge Healthcare Coils (Usa Instruments, Inc.) · Radiology
Jan 2026
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K253738 is an FDA 510(k) clearance for the 3.0T AIR 32CH HNA, a Coil, Magnetic Resonance, Specialty (Class II — Special Controls, product code MOS), submitted by Ge Healthcare Coils (Usa Instruments, Inc.) (Aurora, US). The FDA issued a Cleared decision on January 23, 2026, 60 days after receiving the submission on November 24, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K253738 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 2025
Decision Date January 23, 2026
Days to Decision 60 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MOS — Coil, Magnetic Resonance, Specialty
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1000

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