FDA 510(k)

掌上式超音波診斷系統（MT10P/MT10）

K 號：K260111 · 2026-05-14

申請人Mytech Intelligence (Shenzhen) Co., Ltd.

決定日期2026-05-14

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

Palmtop Ultrasound Diagnostic System (MT10P/MT10) is the device name listed in this FDA 510(k) record. The listed applicant is Mytech Intelligence (Shenzhen) Co., Ltd.. It received FDA 510(k) clearance on 2026-05-14 under 510(k) number K260111. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Palmtop Ultrasound Diagnostic System (MT10P/MT10)?

Palmtop Ultrasound Diagnostic System (MT10P/MT10) is a medical device that received FDA 510(k) clearance on 2026-05-14. The listed applicant is Mytech Intelligence (Shenzhen) Co., Ltd.. The 510(k) number is K260111.

When did Palmtop Ultrasound Diagnostic System (MT10P/MT10) receive FDA 510(k) clearance?

Palmtop Ultrasound Diagnostic System (MT10P/MT10) received FDA 510(k) clearance on 2026-05-14, under 510(k) number K260111.

Who is the listed applicant for Palmtop Ultrasound Diagnostic System (MT10P/MT10)?

The FDA 510(k) record lists Mytech Intelligence (Shenzhen) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Palmtop Ultrasound Diagnostic System (MT10P/MT10)?

The FDA product code for Palmtop Ultrasound Diagnostic System (MT10P/MT10) is IYN.

相關器械（代碼：IYN）

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：IYN）

官方來源