Nexus DRF, Digital Imaging Software

GUDID 00854344007474

Nexus DRF v3.1.2

VAREX IMAGING CORPORATION

X-ray system computer, diagnostic, general-purpose

• Primary Device ID: 00854344007474
• NIH Device Record Key: 5e8e98a2-84c8-4a0d-96db-5f8f060eff50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nexus DRF, Digital Imaging Software
• Version Model Number: v3.1.2
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854344007474 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130318

FDA Product Code

• JAA: System, X-Ray, Fluoroscopic, Image-Intensified

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: 2019-09-30
• Device Publish Date: 2019-09-20

On-Brand Devices [Nexus DRF, Digital Imaging Software]

• 00854344007245: v3.1.1
• 00854344007474: Nexus DRF v3.1.2