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uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K230162

by Shanghai United Imaging Healthcare Co., Ltd.

Identifiers

510(k) Number
K230162 FDA 510(k)
FDA Product Code
JAK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1750 FDA 510(k)
Regulation Number
892.1750 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The uCT 760 and uCT 780 are computed tomography (CT) X-ray systems designed to generate cross-sectional images of the body through computer reconstruction of X-ray transmission data. These systems incorporate dual-energy analysis capabilities, enabling enhanced imaging for improved diagnostic accuracy in various clinical applications, including cardiovascular, pulmonary, and oncological assessments.

These devices are intended for use in radiology departments within healthcare facilities and are supplied as reusable medical equipment. The uCT 760 and uCT 780 comply with FDA 510(k) clearance under the classification of Computed Tomography X-Ray Systems (Product Code JAK) and meet the requirements of the Medical Device Regulation (MDR). They are not single-use and do not require sterilization between patients, as they are designed for institutional use under controlled conditions.

Frequently asked questions

Are these CT systems designed for single-use or repeated use in a clinical setting?

The uCT 760 and uCT 780 are not single-use devices. They are reusable medical equipment intended for institutional use under controlled conditions, meaning they are meant to be operated repeatedly within healthcare facilities like radiology departments without requiring sterilization between patients.

What types of clinical assessments can these CT systems improve with their dual-energy analysis feature?

The dual-energy analysis capability of the uCT 760 and uCT 780 enhances imaging for cardiovascular, pulmonary, and oncological assessments, helping to improve diagnostic accuracy in these specialized areas by providing more detailed cross-sectional images.

How are these devices regulated, and what does that mean for healthcare providers?

The uCT 760 and uCT 780 hold FDA 510(k) clearance under the classification of Computed Tomography X-Ray Systems (Product Code JAK) and comply with the Medical Device Regulation (MDR). This means they meet established safety and performance standards for CT imaging in the U.S. and EU markets, ensuring they can be legally used in radiology departments after proper installation and training.

What kind of maintenance or special handling is required for these reusable CT systems?

Since these systems are reusable and not single-use, they must be maintained under controlled institutional conditions as specified by the manufacturer. While they do not require sterilization between patients, routine cleaning, calibration, and preventive maintenance are essential to ensure consistent performance and safety, following the manufacturer’s guidelines.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF August 1, 2023 Shanghai United Imaging Healthcare Co., Ltd., uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual ..., uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780… - FDA.report

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shanghai United Imaging Healthcare Co., Ltd.

Sources (2)

  • FDA 510(k) K230162 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026