Xperius Ultrasound System

• • Ongoing Z-2055-2025 FDA Class II ·initiated 28 May 2025 ·on shared 510(k) K163020

  Ultrasound transducer devices were refurbished beyond their useful life.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K163020 ↗

FDA Product Code

IYN

Device Class

Class II

Regulation

21 CFR Part 892.1550

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• What is the Xperius Ultrasound System used for?

  The Xperius Ultrasound System is a diagnostic imaging device designed for real-time visualization of internal body structures using high-frequency sound waves. It supports various clinical applications including musculoskeletal, vascular, obstetric, gynecological, and abdominal imaging to help clinicians assess anatomy, pathology, and provide procedural guidance.

• How is the Xperius Ultrasound System supplied and what are its intended environments?

  The system is supplied as a cart-based, portable imaging solution intended for use in clinical environments such as hospitals, outpatient clinics, and procedural suites. It is designed for single-user operation and follows standard electronic medical equipment protocols for storage and handling to ensure operational integrity.

• Is the Xperius Ultrasound System single-use or reusable?

  The Xperius Ultrasound System is not designed for sterilization or reuse. It is intended for single-user operation in clinical settings. The device adheres to MRI safety standards for non-MRI environments as specified in its regulatory submissions.

• What transducer options are available with the Xperius Ultrasound System?

  The Xperius Ultrasound System integrates multiple transducer options to accommodate various anatomical regions and examination requirements. This flexibility allows clinicians to select the appropriate transducer for different imaging needs across musculoskeletal, vascular, obstetric, gynecological, and abdominal applications.

• What is the regulatory status of the Xperius Ultrasound System?

  The Xperius Ultrasound System is authorized for commercial distribution in the United States under an FDA 510(k) clearance with number K163020. It was classified as substantially equivalent and reviewed by the Radiology advisory committee, intended for diagnostic and procedural imaging applications as defined by its regulatory classification.