FDA 510(k)

Handheld Ultrasound Scanner

K号: K261288 · 2026-07-30

决定日期2026-07-30

产品代码IYN

咨询委员会RA

决定Substantially Equivalent

器械摘要

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.

常见问题

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.

相关器械（代码：IYN）

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器械摘要

常见问题

相关临床试验

相关器械（代码：IYN）

官方来源