XRpad Digital X-Ray Detector System 95510981

GUDID 00812589020092

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.

Perkinelmer, Inc.

Flat panel x-ray detector integration unit
Primary Device ID00812589020092
NIH Device Record Key8ab0e44e-51b6-477b-a468-4bafb5cb31fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameXRpad Digital X-Ray Detector System
Version Model NumberXRpad2 4336 HWC-M
Catalog Number95510981
Company DUNS623897670
Company NamePerkinelmer, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+496123971300
EmailMI.CustomerService@PerkinElmer.com
Phone+496123971300
EmailMI.CustomerService@PerkinElmer.com

Device Dimensions

Depth15.5 Millimeter
Depth15.5 Millimeter
Depth15.5 Millimeter
Depth15.5 Millimeter
Depth15.5 Millimeter
Depth15.5 Millimeter
Depth15.5 Millimeter
Depth15.5 Millimeter

Operating and Storage Conditions

Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100812589020092 [Primary]

FDA Product Code

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

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-02-21
Device Publish Date2017-05-17

On-Brand Devices [XRpad Digital X-Ray Detector System]

00812589020139Rechargeable Lithium-Ion Battery Charger for use with PerkinElmer XRpad Battery Only
00812589020108XRpad2 3025 is a lightweight wireless cassette detector with advanced features enabling digital
00812589020092XRpad2 4336 is a lightweight wireless cassette detector with advanced features enabling digital
00812589020078The PerkinElmer XRpad 4336 MED is a wireless, light weight, cassette-sized flat panel detector f

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.