XRPad2 95510607

GUDID 00810751030009

XRpad2 4343 is a lightweight wireless cassette detector with advanced features enabling digital radiography as never seen before. Featuring best-in-class 100 um pixel size, direct deposition CsI scintillator and excellent DQE, XRpad2 4343 enables high resolution imaging with reduced X-ray exposure. Design of the second-generation XRpad is lightweight, robust and ergonomic, permitting easy lifting from table top. Automatic Exposure Detection, on-board corrections, and wireless access point mode make system integration quick and simple. New features of the XRpad2 4343 include fast preview, internal image storage, and magnetic connector for docking. Continuous imaging at up to 8 fps facilitates advanced applications such as tomosynthesis, dual energy subtraction, and image stitching.

VAREX IMAGING WEST, LLC

Indirect flat panel x-ray detector
Primary Device ID00810751030009
NIH Device Record Keycd744f2e-9268-462a-ae83-4864f89b47c1
Commercial Distribution StatusIn Commercial Distribution
Brand NameXRPad2
Version Model Number4343 HWC-M
Catalog Number95510607
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

Device Dimensions

Weight3.8 Kilogram

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100810751030009 [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

On-Brand Devices [XRPad2]

00810751030047XRpad2 4336 is a lightweight wireless cassette detector with advanced features enabling digital
00810751030030XRpad2 3025 is a lightweight wireless cassette detector with advanced features enabling digital
00810751030009XRpad2 4343 is a lightweight wireless cassette detector with advanced features enabling digital

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