HealthOST

GUDID 07290018016114

NANO-X AI LTD

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• Primary Device ID: 07290018016114
• NIH Device Record Key: 27bb8657-8bd5-4830-8b1f-f763b78fd1ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HealthOST
• Version Model Number: 1.1
• 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	07290018016114 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213944

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: 2022-08-09
• Device Publish Date: 2022-08-01

On-Brand Devices [HealthOST]

• 07290018016114: 1.1
• 07290018016145: 1.1