uMI 780 PET/CT System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K172143

by Shanghai United Imaging Healthcare Co., Ltd.

Identifiers

510(k) Number: K172143 FDA 510(k)
FDA Product Code: KPS FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 892.1200 FDA 510(k)
Regulation Number: 892.1200 FDA 510(k)
Advisory Committee: Radiology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The uMI 780 PET/CT System is a whole-body tomography device combining Positron Emission Tomography (PET) and Computed Tomography (CT) imaging. It is designed to provide high-resolution, ultra-fast scans for comprehensive diagnostic evaluation, enabling simultaneous metabolic and anatomical assessment in oncology, cardiology, and neurology.

This system is intended for use in radiology departments and is supplied as a reusable medical device. It features integrated-light-guide digital PET detectors for enhanced sensitivity and speed, with AI-empowered workflows and image reconstruction. The device holds FDA 510(k) clearance and complies with the Medical Device Directive (MDD), ensuring regulatory adherence for clinical deployment.

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: uMI 780: HD Digital PET/CT | United-Imaging Healthcare, uMI® 780: Digital PET/CT | United-Imaging Healthcare, Whole-body tomography PET/CT scanner - uMI 780 - Shanghai United ..., United Imaging uMI 780 — XRAYN

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K172143	Class II	Active

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Manufacturer

Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.

Sources (2)

FDA 510(k) K172143 24 fields · synced Oct 6, 2026
EUDAMED 1 fields · synced May 19, 2026