Ultrasound Therapy Workstation (XMS-UET2)— 510(k) K244041

Name: FDA 510(k) clearance K244041
Creator: U.S. Food and Drug Administration
Published: 2025-10-07

Substantially Equivalent

Xemis Medical Technology (Shenzhen) Co., Ltd.

FDA 510(k) clearance K244041 for Ultrasound Therapy Workstation (XMS-UET2), Substantially Equivalent on 2025-10-07. Applicant: Xemis Medical Technology (Shenzhen) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Xemis Medical Technology (Shenzhen) Co., Ltd.
Product code: Code IMG
Device class: Class 2
Regulation: 21 CFR 890.5860
Advisory panel: Physical Medicine
Date received: 2024-12-30
Decision date: 2025-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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