# K260111: Palmtop Ultrasound Diagnostic System (MT10P/MT10)

- Pathway: 510(k) (Traditional)
- Applicant: Mytech Intelligence (Shenzhen) Co., Ltd.
- Decided: May 14, 2026 after 120 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K935595 (1995). 104 ancestors in all.
No later device cites it as a predicate yet.
0 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211321: Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL), Guangzhou Sonostar Technologies Co., Ltd. (2022) Summary page 6.
- K172750: Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe), Guangzhou Sonostar Technologies Co., Ltd. (2018) Summary page 6.

## Indications for use
The Palmtop Ultrasound Diagnostic System (Probe Model: C3-5) is intended for diagnostic ultrasound echo imaging measurement, and analysis of the human body for general clinical applications including obstetrics(OB), gynecology (GY) and general(abdominal) imaging. The Palmtop Ultrasound Diagnostic System (Probe Model: L7-10) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including small organ and peripheral vessel imaging.

Source page: https://510kreport.com/device/K260111
Methodology: https://510kreport.com/methodology