AccessGUDID - DEVICE: XRpad Digital X-Ray Detector System (00812589020108)

GUDID

Device Identifier (DI) Information

Brand Name: XRpad Digital X-Ray Detector System
Version or Model: XRpad2 3025 HWC-M
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 95510991
Company Name: Perkinelmer, Inc.

Primary DI Number: 00812589020108
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 623897670 *Terms of Use

Device Description: XRpad2 3025 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 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.

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?
60265	Flat panel x-ray detector integration unit	A portable, electrically-powered device intended to enable a direct flat panel detector (not included) to be integrated as part of an analogue x-ray [i.e., screen-film, computerized radiography (plate)] system to convert the analogue x-ray system into a digital x-ray system (retrofit) using the same modality components. It is typically an electronic box which is integrated into the analogue x-ray system via wired connections to each of the components (i.e., generator, exposure button, workstation and detector), whereby it synchronizes the original analogue generator with the direct flat panel detector.	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 [?]
Premarket Submission Number Not Available/Not Released

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

Clinically Relevant Size

[?]

Size Type Text
Weight: 1.8 Kilogram
Width: 282 Millimeter
Length: 332 Millimeter
Depth: 15.5 Millimeter

Device Record Status

Public Device Record Key: facb7fa4-b9c0-437b-a41d-c210d45c6e2c
Public Version Date: February 21, 2019
Public Version Number: 3
DI Record Publish Date: May 17, 2017