FDA 510(k)

3.0T 16ch AIR AA

K-Number: K223378 · 2023-01-03

ApplicantGe Healthcare Coils (Usa Instruments, Inc.)

Decision Date2023-01-03

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

3.0T 16ch AIR AA is a medical device manufactured by Ge Healthcare Coils (Usa Instruments, Inc.). It received FDA 510(k) clearance on 2023-01-03 under approval number K223378. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3.0T 16ch AIR AA?

3.0T 16ch AIR AA is a medical device that received FDA 510(k) clearance on 2023-01-03. It is manufactured by Ge Healthcare Coils (Usa Instruments, Inc.). The 510(k) number is K223378.

When was 3.0T 16ch AIR AA approved by the FDA?

3.0T 16ch AIR AA received FDA 510(k) clearance on 2023-01-03, under approval number K223378.

What company makes 3.0T 16ch AIR AA?

3.0T 16ch AIR AA is manufactured by Ge Healthcare Coils (Usa Instruments, Inc.).

What is the FDA product code for 3.0T 16ch AIR AA?

The FDA product code for 3.0T 16ch AIR AA is MOS.

Other Devices by Ge Healthcare Coils (Usa Instruments, Inc.)

K172695AIR Anterior Array, AIR Posterior Array K16320548CH Head Coil K1825043.0T Air MP M, 3.0T Air MP L K18066648CH Head Coil K2537383.0T AIR 32CH HNA

Related Devices (Code: MOS)

K16262316ch T/R Hand Wrist CoilQuality Electrodynamics, LLC K162966TxRx Knee 15 Flare MR Coil 1.5TQuality Electrodynamics, LLC K163066TxRx Knee 15 Flare MR Coil 3.0TQuality Electrodynamics, LLC K162863dS Small Extremity 16CH 1.5T CoilInvivo Therapeutics Corporation K16202916ch T/R Knee CoilQuality Electrodynamics, LLC K162079TRILLIUM Oval Head Coil 32Hitachi Medical Systems America, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.