Varex Digital Imaging Software, Nexus DR

FDA UDI

Class II (US FDA UDI)

by Varex Imaging Corporation

Identity

Trade Name: Varex Digital Imaging Software, Nexus DR FDA UDI
Generic Name: Angiographic x-ray system application software FDA UDI
Device Name: Digital image acquisition system designed to automate patient work flow that includes image processing algorithms for imaging. FDA UDI
Model / Reference: v4.9 FDA UDI
Description: Digital image acquisition system designed to automate patient work flow that includes image processing algorithms for imaging. FDA UDI

Identifiers

Primary DI / UDI-DI: 00854344007658 FDA UDI
FDA Product Code: JAA FDA UDI
MQB FDA UDI
GMDN Term: Angiographic x-ray system application software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1650 FDA UDI
892.1680 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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Angiographic x-ray system application software

Varex Digital Imaging Software, Nexus DR by Varex Imaging Corporation — 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: Varex Imaging Corporation

Sources (1)

FDA UDI 09ee00ee-b952-442d-81d9-f34f70b4d0da 34 fields · synced Jun 9, 2026