Varex Digital Imaging System, Nexus, RF/DR, Digital Receptor

GUDID 00854344007054

VAREX IMAGING CORPORATION

X-ray system computer, diagnostic, general-purpose

• Primary Device ID: 00854344007054
• NIH Device Record Key: 022c1688-179a-4d8e-8ad8-d0d3672bc254
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Varex Digital Imaging System, Nexus, RF/DR, Digital Receptor
• Version Model Number: Nexus-DRF
• 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	00854344007054 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130318

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-24

Devices Manufactured by VAREX IMAGING CORPORATION

• 00854344007764 - Varex Digital Imaging Software, Nexus DR, v4.17: 2025-05-13
• 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