XRpad Digital X-Ray Detector System - XRpad2 4336 is a lightweight wireless cassette - Perkinelmer, Inc.

Duns Number:623897670

Device Description: XRpad2 4336 is a lightweight wireless cassette detector with advanced features enabling di XRpad2 4336 is a lightweight wireless cassette detector with advanced features enabling digital radiography as never seen before. Featuring best-in-class 100 μm 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.

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More Product Details

Catalog Number

95510981

Brand Name

XRpad Digital X-Ray Detector System

Version/Model Number

XRpad2 4336 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

-

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

8ab0e44e-51b6-477b-a468-4bafb5cb31fb

Public Version Date

February 21, 2019

Public Version Number

3

DI Record Publish Date

May 17, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PERKINELMER, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 5