XRpad Digital X-Ray Detector System 95510925-02

GUDID 00812589020078

The PerkinElmer XRpad 4336 MED is a wireless, light weight, 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 15 million pixel image matrix, a best-in-class 100 μm pixel pitch, and a directly deposited CsI scintillator, the PerkinElmer XRpad 4336 MED provides exceptional image quality. True 35 cm × 43 cm imaging area per the ISO 4090 cassette standard is provided, along with a removable, rechargeable battery. A robust and lightweight aluminum frame with carbon-fiber entrance window and back cover allow for easier placement and cleaning. Automatic Exposure Detection simplifies integration.

Perkinelmer, Inc.

Flat panel x-ray detector integration unit

• Primary Device ID: 00812589020078
• NIH Device Record Key: d28037c7-169e-434e-bc65-6b9b130d56b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XRpad Digital X-Ray Detector System
• Version Model Number: XRpad 4336 MED
• Catalog Number: 95510925-02
• Company DUNS: 623897670
• Company Name: Perkinelmer, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +496123971300
• Email: MI.CustomerService@PerkinElmer.com
• Phone: +496123971300
• Email: MI.CustomerService@PerkinElmer.com

Device Dimensions

• Depth: 15 Millimeter
• Depth: 15 Millimeter
• Depth: 15 Millimeter
• Depth: 15 Millimeter
• Depth: 15 Millimeter
• Depth: 15 Millimeter
• Depth: 15 Millimeter
• Depth: 15 Millimeter

Operating and Storage Conditions

• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812589020078 [Primary]

FDA Product Code

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

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-02-21
• Device Publish Date: 2016-07-29

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

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