Varex Digital Imaging Software, Nexus DR, v4.12

GUDID 00854344007696

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: 00854344007696
• NIH Device Record Key: a8892999-193e-45ae-a5ef-cbbdaffc8508
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Varex Digital Imaging Software, Nexus DR, v4.12
• Version Model Number: Nexus DR, v4.12
• 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	00854344007696 [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

Devices Manufactured by VAREX IMAGING CORPORATION

• 00854344007740 - Varex Digital Imaging Software, Nexus DR, v4.15: 2024-03-19
• 00854344007733 - Varex Digital Imaging Software, Nexus DR, v4.13: 2023-09-26
• 00854344007610 - Varex Digital Imaging Software, Nexus DRF, v3.6: 2023-06-07
• 00854344007634 - Varex Digital Imaging Software, Nexus, DRF, v3.7: 2023-06-07
• 00854344007672 - Varex Digital Imaging Software, Nexus DR, v4.10: 2023-06-07
• 00854344007696 - Varex Digital Imaging Software, Nexus DR, v4.12: 2023-06-07
• 00854344007696 - Varex Digital Imaging Software, Nexus DR, v4.12: 2023-06-07
• 00854344007726 - Varex Digital Imaging Software, Nexus DR, v4.13: 2023-06-07
• 08718755002461 - Varex Imaging: 2022-03-14 An Ionization Chamber is a device that is placed between the patient and an x-ray image receptor to assist the Automatic Exposur