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 ID: 00810751030009
• NIH Device Record Key: cd744f2e-9268-462a-ae83-4864f89b47c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XRPad2
• Version Model Number: 4343 HWC-M
• Catalog Number: 95510607
• Company DUNS: 080830509
• Company Name: VAREX IMAGING WEST, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(408) 496-1216
• Email: mi.customerservice@vareximaging.com

Device Dimensions

• Weight: 3.8 Kilogram

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810751030009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181526

FDA Product Code

• MQB: Solid State X-Ray Imager (Flat Panel/Digital Imager)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-11
• Device Publish Date: 2019-06-03

On-Brand Devices [XRPad2]

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