XRPad2

Basic Information

• Brand Name: XRPad2
• Primary DI: 00810751030047
• Version / Model: 4336 HWC-M
• Catalog Number: 95510981
• Company Name: VAREX IMAGING WEST, LLC
• Labeler DUNS: 080830509
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-03
• Public Version: 1
• Public Version Date: 2019-06-11
• Public Version Status: New
• Public Device Record Key: 0fff1474-edc7-4edd-996a-1858e47076a8

Device Description

XRpad2 4336 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 4336 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 4336 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	892.1680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61108	Indirect flat panel x-ray detector	An electrically-powered, cassette-like device intended to be used as part of an x-ray system to detect x-ray images following exposure, and create a digital signal; it is not dedicated to imaging of a specific anatomy. It includes two types of transducing technology (i.e., indirect): a scintillator [e.g. caesium iodide (CsI)] screen converts x-ray energy into light, followed by the conversion of light into a digital signal by photodiode array. The image data can be sent to an appropriate processing unit through a wired or wireless connection (e.g., Wi-Fi). It may be used in place of a fixed detector in x-ray imaging systems, e.g., as part of a digital imaging conversion system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810751030047	GS1
Previous	00812589020092	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K161966	000

Device Sizes

Type	Value	Unit	Text
Depth	15.5	Millimeter
Length	460	Millimeter
Width	384	Millimeter
Weight	3.2	Kilogram

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 20 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius