uOmniscan (UDI uOmniscan)
Manufactured by Shanghai United Imaging Healthcare Co., Ltd.
Device Regulatory Overview
The uOmniscan (Model/Catalog Number: uOmniscan) is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. This product is indexed under FDA Product Code / Category Classification LLZ within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
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Technical Specifications
- Model Number
- uOmniscan
- Product Code / EMDN
- LLZ
- Device Name
- Medical Image Management and Processing System
- Database Sync Date
- 2026-08-09 09:06:43
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of uOmniscan?
The registered manufacturer of record for uOmniscan is Shanghai United Imaging Healthcare Co., Ltd..
What is the Primary UDI-DI identifier for uOmniscan?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is uOmniscan.
What classification code is assigned to this device?
This device is registered under product classification code LLZ.
Similar Classification Devices (LLZ)
Other Devices by Shanghai United Imaging Healthcare Co., Ltd.
Programmatic Export
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