Cleared Abbreviated

K253738 - 3.0T AIR 32CH HNA (FDA 510(k) Clearance)

Class II Radiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K253738 · Ge Healthcare Coils (Usa Instruments, Inc.) · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2026
Decision
60d
Days
Class 2
Risk

K253738 is an FDA 510(k) clearance for the 3.0T AIR 32CH HNA. 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 23, 2026 after a review of 60 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 K253738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 107d · This submission: 60d
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 487
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K253738.
0.55T 12Ch Breast Coil
K260947 · Neocoil, LLC · Apr 2026
HD 8Ch Wrist Array
K252587 · Shenzhen RF Tech Co., Ltd. · Apr 2026
GEM Flex Coil 16-L Array, 3.0T Receive Only
K252876 · Shenzhen RF Tech Co., Ltd. · Apr 2026
Smart Fit TorsoCardiac 1.5T
K260519 · Philips Healthcare (Suzhou) Co., Ltd. · Mar 2026
GEM Flex Coil 16-L Array, 1.5T Receive Only
K252179 · Shenzhen RF Tech Co., Ltd. · Feb 2026
dS Base 1.5T
K254190 · Philips Medical Systems Nederland B.V. · Jan 2026