Varex Digital Imaging Software, Nexus DR, v4.13

GUDID 00854344007726

VAREX IMAGING CORPORATION

X-ray system computer, diagnostic, general-purpose X-ray system computer, diagnostic, general-purpose X-ray system computer, diagnostic, general-purpose X-ray system computer, diagnostic, general-purpose X-ray system computer, diagnostic, general-purpose X-ray system computer, diagnostic, general-purpose X-ray system computer, diagnostic, general-purpose X-ray system computer, diagnostic, general-purpose X-ray system computer, diagnostic, general-purpose X-ray system computer, diagnostic, general-purpose X-ray system computer, diagnostic, general-purpose X-ray system computer, diagnostic, general-purpose X-ray system computer, diagnostic, general-purpose X-ray system computer, diagnostic, general-purpose X-ray system computer, diagnostic, general-purpose X-ray system computer, diagnostic, general-purpose X-ray system computer, diagnostic, general-purpose

• Primary Device ID: 00854344007726
• NIH Device Record Key: 0238f8ce-8636-4d56-bb35-2b7e7b1c6109
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Varex Digital Imaging Software, Nexus DR, v4.13
• Version Model Number: Nexus DR, v4.13
• Company DUNS: 080506857
• Company Name: VAREX IMAGING CORPORATION
• 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: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854344007726 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193238

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: 2023-06-07
• Device Publish Date: 2023-05-30

On-Brand Devices [Varex Digital Imaging Software, Nexus DR, v4.13]

• 00854344007726: Nexus DR, v4.13
• 00854344007733: Nexus DR, v4.14