Palmtop Ultrasound Diagnostic System (MT10P/MT10)— 510(k) K260111
Substantially EquivalentMytech Intelligence (Shenzhen) Co., Ltd.
FDA 510(k) clearance K260111 for Palmtop Ultrasound Diagnostic System (MT10P/MT10), Substantially Equivalent on 2026-05-14. Applicant: Mytech Intelligence (Shenzhen) Co., Ltd.. Device class: 2.
Summary
Mytech Intelligence (Shenzhen) filed the Palmtop Ultrasound Diagnostic System (MT10P/MT10) under IYN, pulsed Doppler ultrasonic imaging systems.
Class II, 21 CFR 892.1550. Radiology is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Mytech filed from Shenzhen, China. Review took 120 calendar days (January 14 to May 14, 2026).
Clearance details
- Applicant
- Mytech Intelligence (Shenzhen) Co., Ltd.
- Product code
- Product code IYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.1550
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code IYN
view all- K261617 — Diagnostic Ultrasound System (11+ models)
- K263150 — V10 Diagnostic Ultrasound System +10 more
- K261933 — Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
- K262548 — EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
- K263182 — EVO X30 Diagnostic Ultrasound System +8 more
Adverse events under product code IYN
product code IYN- Death
- 25
- Injury
- 163
- Malfunction
- 1,538
- Other
- 4
- Total
- 1,730
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.