Nanox.ARC X

GUDID 07290018465011

NANO-X IMAGING LTD

Multi-directional tomography x-ray system

• Primary Device ID: 07290018465011
• NIH Device Record Key: c43386c1-b869-4d8b-8270-44efcdffe0ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nanox.ARC X
• Version Model Number: Nanox.ARC X
• Company DUNS: 521092973
• Company Name: NANO-X IMAGING LTD
• 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	07290018465011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250850

FDA Product Code

• IZF: System, X-Ray, Tomographic

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: 2025-09-12
• Device Publish Date: 2025-09-04

Devices Manufactured by NANO-X IMAGING LTD

• 07290018465011 - Nanox.ARC X: 2025-09-12
• 07290018465011 - Nanox.ARC X: 2025-09-12
• 07290018465004 - Nanox.ARC: 2023-11-03