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FDA 510(k)

Ultrasound Therapy Workstation (XMS-UET2)

K-Number: K244041 · 2025-10-07

ApplicantXemis Medical Technology (Shenzhen) Co., Ltd.
Decision Date2025-10-07
Product CodeIMG
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Ultrasound Therapy Workstation (XMS-UET2) is the device name listed in this FDA 510(k) record. The listed applicant is Xemis Medical Technology (Shenzhen) Co., Ltd.. It received FDA 510(k) clearance on 2025-10-07 under 510(k) number K244041. The device is classified under product code IMG. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ultrasound Therapy Workstation (XMS-UET2)?

Ultrasound Therapy Workstation (XMS-UET2) is a medical device that received FDA 510(k) clearance on 2025-10-07. The listed applicant is Xemis Medical Technology (Shenzhen) Co., Ltd.. The 510(k) number is K244041.

When did Ultrasound Therapy Workstation (XMS-UET2) receive FDA 510(k) clearance?

Ultrasound Therapy Workstation (XMS-UET2) received FDA 510(k) clearance on 2025-10-07, under 510(k) number K244041.

Who is the listed applicant for Ultrasound Therapy Workstation (XMS-UET2)?

The FDA 510(k) record lists Xemis Medical Technology (Shenzhen) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ultrasound Therapy Workstation (XMS-UET2)?

The FDA product code for Ultrasound Therapy Workstation (XMS-UET2) is IMG.

Other records listing Xemis Medical Technology (Shenzhen) Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243993Photon Therapy Apparatus (BL-10)

Related Devices (Code: IMG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K153559OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy SystemAccelerated Care Plus (Acp)

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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