Varex Digital Imaging Software, Nexus DR, v4.16

GUDID 00854344007757

VAREX IMAGING CORPORATION

X-ray system computer, diagnostic, general-purpose

• Primary Device ID: 00854344007757
• NIH Device Record Key: e0941a26-8b6e-4f23-93fb-484e2eeb1120
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Varex Digital Imaging Software, Nexus DR, v4.16
• Version Model Number: Nexus DR, v4.16
• 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	00854344007757 [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: 2024-07-01
• Device Publish Date: 2024-06-21

Devices Manufactured by VAREX IMAGING CORPORATION

• 08718755003550 - Varex Imaging: 2025-03-05 An Ionization Chamber is a device that is placed between the patient and an x-ray image receptor to assist the Automatic Exposur
• 08718755003574 - Varex Imaging: 2025-03-05 An Ionization Chamber is a device that is placed between the patient and an x-ray image receptor to assist the Automatic Exposur
• 08718755003864 - Varex Imaging: 2025-03-05 An Ionization Chamber is a device that is placed between the patient and an x-ray image receptor to assist the Automatic Exposur
• 08718755003871 - Varex Imaging: 2025-03-05 An Ionization Chamber is a device that is placed between the patient and an x-ray image receptor to assist the Automatic Exposur
• 08718755003888 - Varex Imaging: 2025-03-05 An Ionization Chamber is a device that is placed between the patient and an x-ray image receptor to assist the Automatic Exposur
• 08718755004021 - Varex Imaging: 2025-03-05 An Ionization Chamber is a device that is placed between the patient and an x-ray image receptor to assist the Automatic Exposur
• 08718755003840 - Varex Imaging: 2025-03-04 An Ionization Chamber is a device that is placed between the patient and an x-ray image receptor to assist the Automatic Exposur
• 08718755003444 - Varex Imaging: 2024-12-06 An Ionization Chamber is a device that is placed between the patient and an x-ray image receptor to assist the Automatic Exposur