XRpad Digital X-Ray Detector System

Basic Information

• Brand Name: XRpad Digital X-Ray Detector System
• Primary DI: 00812589020085
• Version / Model: XRpad 4343 F MED
• Catalog Number: 95510935-02
• Company Name: Perkinelmer, Inc.
• Labeler DUNS: 623897670
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-29
• Public Version: 3
• Public Version Date: 2019-02-21
• Public Version Status: Update
• Public Device Record Key: 7dab0691-300c-4dcd-9a95-afe640c17c59

Device Description

The PerkinElmer XRpad 4343 F MED is a lightweight, cassette-sized flat panel detector for digital radiography. It fits into a conventional table or wall-stand bucky, just like a film-screen cassette. Featuring a 18.7 million pixel image matrix, a best-in-class 100 μm pixel pitch, and a direct deposited CsI scintillator, the PerkinElmer XRpad 4343 F MED provides exceptional image quality with a true 43 cm × 43 cm imaging area. A robust and lightweight aluminum frame with carbon-fiber entrance window allows for easier placement and cleaning. Automatic Exposure Detection simplifies integration.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	892.1680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812589020085	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Weight	4.1	Kilogram
Width	460	Millimeter
Length	460	Millimeter
Depth	15	Millimeter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 30 – 70 Percent (%) Relative Humidity