U-Systems Diagnostic Ultrasound System U-2000
by U-Systems, Inc. 510(k)
Active
510(k) K013848
Overview
The U-Systems Diagnostic Ultrasound System U-2000 is a diagnostic imaging device classified as a System, Imaging, Pulsed Doppler, Ultrasonic under FDA nomenclature. It is designed to acquire and process two-dimensional ultrasound images, enabling three-dimensional reconstruction for diagnostic purposes. The system supports digital image capture, analysis, storage, and retrieval, facilitating advanced ultrasound-based diagnostics in radiology. Its primary function is to generate high-resolution ultrasound visualizations for clinical assessment.
This device is intended for use in clinical radiology settings and has received FDA 510(k) clearance under the Traditional review pathway, classified as Substantially Equivalent (SESE). It operates with compatible transducers (e.g., USI-2000 series) and is not specified as single-use or reusable in the regulatory submission. No MRI safety or sterility requirements are explicitly stated in the available data. The system is supplied as a standalone diagnostic imaging unit, with no additional regulatory markings beyond its FDA clearance.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK013848 | Date8 Apr 2002 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- IYN
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1550
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from U-Systems, Inc.
Questions
What is the primary purpose of the U-Systems U-2000 Diagnostic Ultrasound System?
The U-Systems U-2000 Diagnostic Ultrasound System is designed to acquire and process two-dimensional ultrasound images, enabling three-dimensional reconstruction for diagnostic purposes. This capability supports advanced ultrasound-based assessments in clinical radiology, providing high-resolution visualizations to aid clinicians in evaluating internal structures.
How is the U-Systems U-2000 Diagnostic Ultrasound System supplied?
The U-Systems U-2000 is supplied as a standalone diagnostic imaging unit. It requires compatible transducers, such as those from the USI-2000 series, to function. The system is not specified as single-use or reusable in the regulatory data, meaning it is intended for repeated use in clinical settings with appropriate maintenance and cleaning protocols.
Does the U-Systems U-2000 Diagnostic Ultrasound System have any specific sterility or MRI safety requirements?
The available data does not explicitly state any sterility requirements or MRI safety specifications for the U-Systems U-2000 Diagnostic Ultrasound System. Clinicians should follow standard operating procedures for ultrasound equipment to ensure safe and hygienic use, particularly when handling transducers or patient interfaces.
What regulatory pathway was followed for the FDA clearance of the U-Systems U-2000?
The U-Systems U-2000 Diagnostic Ultrasound System received FDA 510(k) clearance under the Traditional review pathway. It was classified as Substantially Equivalent (SESE) to a predicate device, meaning the FDA determined it had the same intended use and technological characteristics as the predicate, with no significant changes in design or function.
What types of transducers are compatible with the U-Systems U-2000?
The U-Systems U-2000 Diagnostic Ultrasound System is designed to operate with compatible transducers, specifically mentioned as the USI-2000 series in the regulatory data. These transducers are essential for capturing ultrasound images and should be selected based on the clinical application, such as abdominal, cardiac, or vascular imaging.