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3.0T 16ch AIR AA

by Ge Healthcare Coils (Usa Instruments, Inc.)

510(k) K223378

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K223378↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Abbreviated NumberK223378 Date3 Jan 2023ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
MOS
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The 3.0T 16ch AIR AA is a receive-only radiofrequency (RF) coil designed for magnetic resonance imaging (MRI) systems operating at 3.0 Tesla. It is classified as a specialty MRI coil and functions as a hydrogen proton signal receiver, capturing anatomical data from human extremities or other specified regions to generate high-resolution images.

This coil is supplied as a reusable, non-sterile device intended for use in MRI environments. It features 16-channel elements with integrated preamplifiers to improve signal-to-noise ratio and image uniformity. The device complies with FDA 510(k) clearance (K223378) and MDR authorisation, adhering to regulatory standards for Class II medical devices (device class 2). Storage and handling must follow manufacturer guidelines to ensure optimal performance and longevity.

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