XRpad 95510935-02

GUDID 00812589020085

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.

VAREX IMAGING WEST, LLC

Indirect flat panel x-ray detector
Primary Device ID00812589020085
NIH Device Record Key9c090bb7-35b0-4395-b048-d5c19bae19af
Commercial Distribution StatusIn Commercial Distribution
Brand NameXRpad
Version Model Number4343 F MED
Catalog Number95510935-02
Company DUNS080830509
Company NameVAREX IMAGING WEST, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(408) 496-1216
Emailmi.customerservice@vareximaging.com
Phone+1(408) 496-1216
Emailmi.customerservice@vareximaging.com

Device Dimensions

Length460 Millimeter
Length460 Millimeter
Length460 Millimeter
Length460 Millimeter
Length460 Millimeter
Length460 Millimeter
Length460 Millimeter
Length460 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100810751030054 [Primary]
GS100812589020085 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-11
Device Publish Date2019-06-03

Devices Manufactured by VAREX IMAGING WEST, LLC

00810751030009 - XRPad22019-06-11 XRpad2 4343 is a lightweight wireless cassette detector with advanced features enabling digital radiography as never seen before
00810751030030 - XRPad2 2019-06-11 XRpad2 3025 is a lightweight wireless cassette detector with advanced features enabling digital radiography as never seen before
00810751030047 - XRPad22019-06-11 XRpad2 4336 is a lightweight wireless cassette detector with advanced features enabling digital radiography as never seen before
00812589020085 - XRpad2019-06-11The 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.
00812589020085 - XRpad2019-06-11 The Varex Imaging XRpad 4343 F MED is a lightweight, cassette-sized flat panel detector for digital radiography. It fits into a

Trademark Results [XRpad]

Mark Image

Registration | Serial
Company
Trademark
Application Date
XRPAD
XRPAD
85477440 4576287 Live/Registered
VAREX IMAGING CORPORATION
2011-11-21

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