XRpad

FDA UDI

Class II (US FDA UDI)

by Varex Imaging West, Llc

Identity

Trade Name: XRpad FDA UDI
Generic Name: Indirect flat panel x-ray detector FDA UDI
Device Name: The Varex Imaging XRpad 4343 F MED is a lightweight, cassette-sized flat panel detector for digital radiography. It fits into a conventional table or wall-stand bucky, just like a film-screen cassette. Featuring a 18.7 million pixel image matrix, a best-in-class 100 um pixel pitch, and a direct deposited CsI scintillator, the XRpad 4343 F MED provides exceptional image quality with a true 43 cm × 43 cm imaging area. A robust and lightweight aluminum frame with carbon-fiber entrance window allows for easier placement and cleaning. Automatic Exposure Detection simplifies integration. FDA UDI
Model / Reference: 4343 F MED FDA UDI
Description: The Varex Imaging XRpad 4343 F MED is a lightweight, cassette-sized flat panel detector for digital radiography. It fits into a conventional table or wall-stand bucky, just like a film-screen cassette. Featuring a 18.7 million pixel image matrix, a best-in-class 100 um pixel pitch, and a direct deposited CsI scintillator, the XRpad 4343 F MED provides exceptional image quality with a true 43 cm × 43 cm imaging area. A robust and lightweight aluminum frame with carbon-fiber entrance window allows for easier placement and cleaning. Automatic Exposure Detection simplifies integration. FDA UDI

Identifiers

Catalog Number: 95510935-02 FDA UDI
Primary DI / UDI-DI: 00810751030054 FDA UDI
510(k) Number: K142698 FDA UDI
FDA Product Code: MQB FDA UDI
GMDN Term: Indirect flat panel x-ray detector FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Width — 460 Millimeter FDA UDI
Weight — 4.1 Kilogram FDA UDI
Depth — 15 Millimeter FDA UDI
Length — 460 Millimeter FDA UDI

Category: Indirect flat panel x-ray detector

XRpad by Varex Imaging West, Llc — 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 West, Llc

Sources (1)

FDA UDI 9c090bb7-35b0-4395-b048-d5c19bae19af 38 fields · synced May 30, 2026