XRpad 95510935-02

GUDID 00812589020085

The Varex Imaging 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 um pixel pitch, and a direct deposited CsI scintillator, the 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.

VAREX IMAGING WEST, LLC

Indirect flat panel x-ray detector

• Primary Device ID: 00812589020085
• NIH Device Record Key: 9c090bb7-35b0-4395-b048-d5c19bae19af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XRpad
• Version Model Number: 4343 F MED
• Catalog Number: 95510935-02
• Company DUNS: 080830509
• Company Name: VAREX IMAGING WEST, LLC
• 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: +1(408) 496-1216
• Email: mi.customerservice@vareximaging.com
• Phone: +1(408) 496-1216
• Email: mi.customerservice@vareximaging.com

Device Dimensions

• Length: 460 Millimeter
• Length: 460 Millimeter
• Length: 460 Millimeter
• Length: 460 Millimeter
• Length: 460 Millimeter
• Length: 460 Millimeter
• Length: 460 Millimeter
• Length: 460 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810751030054 [Primary]
GS1	00812589020085 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142698

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-11
• Device Publish Date: 2019-06-03

Devices Manufactured by VAREX IMAGING WEST, LLC

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• 00810751030030 - XRPad2: 2019-06-11 XRpad2 3025 is a lightweight wireless cassette detector with advanced features enabling digital radiography as never seen before
• 00810751030047 - XRPad2: 2019-06-11 XRpad2 4336 is a lightweight wireless cassette detector with advanced features enabling digital radiography as never seen before
• 00812589020085 - XRpad: 2019-06-11The Varex Imaging 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 um pixel pitch, and a direct deposited CsI scintillator, the 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.
• 00812589020085 - XRpad: 2019-06-11 The Varex Imaging XRpad 4343 F MED is a lightweight, cassette-sized flat panel detector for digital radiography. It fits into a