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FDA 510(k)

Palmtop Ultrasound Diagnostic System (MT10P/MT10)

K-Number: K260111 · 2026-05-14

ApplicantMytech Intelligence (Shenzhen) Co., Ltd.
Decision Date2026-05-14
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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

When was Palmtop Ultrasound Diagnostic System (MT10P/MT10) approved by the FDA?

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

What company makes Palmtop Ultrasound Diagnostic System (MT10P/MT10)?

Palmtop Ultrasound Diagnostic System (MT10P/MT10) is manufactured by Mytech Intelligence (Shenzhen) Co., Ltd..

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.

Related Devices (Code: IYN)

K253716uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus SuperWuhan United Imaging Healthcare Co.,Ltd K254028Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV, e-Autra, Autra 75, Autra 85W, Autra 65, Autra 55, Autra 65i, Autra 90 Elite, Autra 85 Elite, Autra 80 Elite, Autra 75 Elite, Autra 85 CV, Autra 80W, Autra 65 Elite, Autra 55 Elite, Autra 55i, Autra 90 CV, Autra 85, Autra 80, Autra 80 CV, Autra 75 Pro, Autra 75W, Autra 70 Elite, Autra 70, Autra T)Sonoscape Medical Corp. K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic Ultrasound System (MU9T);Diagnostic Ultrasound System (MU9 Exp);Diagnostic Ultrasound System (MU9 Pro);Diagnostic Ultrasound System (MU9 Super);Diagnostic Ultrasound System (MU9P);Diagnostic Ultrasound System (MU9A);Diagnostic Ultrasound System (MU7);Diagnostic Ultrasound System (MU7S);Diagnostic Ultrasound System (MU7T);Diagnostic Ultrasound System (MU7 Exp);Diagnostic Ultrasound System (MU7 Pro);DiagnosShenzhen Mindray Bio-Medical Electronics Co., Ltd. K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC K261132Healium Intelliscan LX192LCHealium Intelliscan Corporation K260589ES-SeriesE-Scopics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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