XRPad2 - XRpad2 3025 is a lightweight wireless cassette - VAREX IMAGING WEST, LLC

Duns Number:080830509

Device Description: XRpad2 3025 is a lightweight wireless cassette detector with advanced features enabling di XRpad2 3025 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 3025 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 3025 include fast preview, internal image storage, and magnetic connector for docking. Continuous imaging at up to 10 fps facilitates advanced applications such as tomosynthesis, dual energy subtraction, and image stitching.

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More Product Details

Catalog Number

95510991

Brand Name

XRPad2

Version/Model Number

3025 HWC-M

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K161942,K161942

Product Code Details

Product Code

MQB

Product Code Name

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

Device Record Status

Public Device Record Key

3e9689d3-0c7f-445a-b025-c2e7352eacd3

Public Version Date

June 11, 2019

Public Version Number

1

DI Record Publish Date

June 03, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VAREX IMAGING WEST, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4