K260111
- 510(k) number
- K260111
- Device name
- Palmtop Ultrasound Diagnostic System (MT10P/MT10)
- Applicant
- Mytech Intelligence (Shenzhen) Co., Ltd. CN
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2026-05-14
- Date received
- 2026-01-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K260111.pdf
Official FDA record: K260111
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.