AccessGUDID - DEVICE: XRPad2 (00810751030009)

GUDID

Device Identifier (DI) Information

Brand Name: XRPad2
Version or Model: 4343 HWC-M
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 95510607
Company Name: VAREX IMAGING WEST, LLC

Primary DI Number: 00810751030009
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080830509 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181526	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Depth: 15.5 Millimeter
Length: 460 Millimeter
Width: 460 Millimeter
Weight: 3.8 Kilogram

Device Record Status

Public Device Record Key: cd744f2e-9268-462a-ae83-4864f89b47c1
Public Version Date: June 11, 2019
Public Version Number: 1
DI Record Publish Date: June 03, 2019