FDA 510(k)

3.0T AIR 32CH HNA

Numéro K : K253738 · 2026-01-23

DemandeurGe Healthcare Coils (Usa Instruments, Inc.)

Date de décision2026-01-23

Code produitMOS

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

3.0T AIR 32CH HNA is the device name listed in this FDA 510(k) record. The listed applicant is Ge Healthcare Coils (Usa Instruments, Inc.). It received FDA 510(k) clearance on 2026-01-23 under 510(k) number K253738. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the 3.0T AIR 32CH HNA?

3.0T AIR 32CH HNA is a medical device that received FDA 510(k) clearance on 2026-01-23. The listed applicant is Ge Healthcare Coils (Usa Instruments, Inc.). The 510(k) number is K253738.

When did 3.0T AIR 32CH HNA receive FDA 510(k) clearance?

3.0T AIR 32CH HNA received FDA 510(k) clearance on 2026-01-23, under 510(k) number K253738.

Who is the listed applicant for 3.0T AIR 32CH HNA?

The FDA 510(k) record lists Ge Healthcare Coils (Usa Instruments, Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3.0T AIR 32CH HNA?

The FDA product code for 3.0T AIR 32CH HNA is MOS.

Autres dossiers indiquant Ge Healthcare Coils (Usa Instruments, Inc.) en tant que demandeur

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

K2233783.0T 16ch AIR AA K1825043.0T Air MP M, 3.0T Air MP L K18066648CH Head Coil K172695AIR Antérieur Array, AIR Postérieur Array K16320548CH Head Coil

Dispositifs connexes (Code : MOS)

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Source officielle

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