FDA 510(k)

Handheld Ultrasound Scanner

Numéro K : K261288 · 2026-07-30

Date de décision2026-07-30

Code produitIYN

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

Handheld Ultrasound Scanner is the device name listed in this FDA 510(k) record. The listed applicant is IMGFAX CO., LTD.. It received FDA 510(k) clearance on 2026-07-30 under 510(k) number K261288. 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 Handheld Ultrasound Scanner?

Handheld Ultrasound Scanner is a medical device that received FDA 510(k) clearance on 2026-07-30. The listed applicant is IMGFAX CO., LTD.. The 510(k) number is K261288.

When did Handheld Ultrasound Scanner receive FDA 510(k) clearance?

Handheld Ultrasound Scanner received FDA 510(k) clearance on 2026-07-30, under 510(k) number K261288.

Who is the listed applicant for Handheld Ultrasound Scanner?

The FDA 510(k) record lists IMGFAX CO., LTD. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Handheld Ultrasound Scanner?

The FDA product code for Handheld Ultrasound Scanner is IYN.

Essais cliniques associés

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Dispositifs connexes (Code : IYN)

Source officielle

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