FDA 510(k)

Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)

Numéro K : K251268 · 2025-12-23

Date de décision2025-12-23

Code produitIYN

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) is the device name listed in this FDA 510(k) record. The listed applicant is Edan Instruments, Inc.. It received FDA 510(k) clearance on 2025-12-23 under 510(k) number K251268. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)?

Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) is a medical device that received FDA 510(k) clearance on 2025-12-23. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K251268.

When did Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) receive FDA 510(k) clearance?

Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) received FDA 510(k) clearance on 2025-12-23, under 510(k) number K251268.

Who is the listed applicant for Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)?

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

What is the FDA product code for Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)?

The FDA product code for Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) is IYN.

Essais cliniques associés

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Autres dossiers indiquant Edan Instruments, Inc. en tant que demandeur

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Dispositifs connexes (Code : IYN)

Source officielle

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