HealthCCSng

GUDID 07290018016169

NANO-X AI LTD

Radiology DICOM image processing application software

• Primary Device ID: 07290018016169
• NIH Device Record Key: 1e566340-5732-424d-a51e-4e40816d50aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HealthCCSng
• Version Model Number: 2.0
• Company DUNS: 600098228
• Company Name: NANO-X AI 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: false
• 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	07290018016169 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241440

FDA Product Code

• JAK: System, X-Ray, Tomography, Computed

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: 2024-11-29
• Device Publish Date: 2024-11-21

On-Brand Devices [HealthCCSng]

• 07290018016138: 1.1
• 07290018016169: 2.0