FDA 510(k)

Handheld Ultrasound Scanner

K-Number: K261288 · 2026-07-30

Decision Date2026-07-30

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: IYN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.