uMI

FDA UDI

Class II (US FDA UDI)

by Shanghai United Imaging Healthcare Co., Ltd.

Identity

Trade Name: uMI FDA UDI
Generic Name: PET/CT system FDA UDI
Device Name: Positron Emission Tomography and Computed Tomography System, mobile configuration FDA UDI
Model / Reference: uMI 550 FDA UDI
Description: Positron Emission Tomography and Computed Tomography System, mobile configuration FDA UDI

Identifiers

Primary DI / UDI-DI: 06971576832057 FDA UDI
510(k) Number: K182237 FDA UDI
K193241 FDA UDI
FDA Product Code: KPS FDA UDI
JAK FDA UDI
GMDN Term: PET/CT system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1200 FDA UDI
892.1750 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: PET/CT system

uMI by Shanghai United Imaging Healthcare Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.

Sources (1)

FDA UDI ac49e4b5-5178-4ef8-b4c0-32669767d8fd 35 fields · synced May 30, 2026