HealthPNX

GUDID 07290018016077

NANO-X AI LTD

Radiology DICOM image processing application software

• Primary Device ID: 07290018016077
• NIH Device Record Key: dc3eebe4-4581-49d2-b6fc-ae6e98242136
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HealthPNX
• Version Model Number: 2.0.0
• 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: 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	07290018016077 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190362

FDA Product Code

• QFM: Radiological Computer-Assisted Prioritization Software For Lesions

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-03-28
• Device Publish Date: 2020-06-12

Devices Manufactured by NANO-X AI LTD

• 07290018016145 - HealthOST: 2023-05-17
• 07290018016138 - HealthCCSng: 2023-05-12
• 07290018016114 - HealthOST: 2022-08-09
• 07290018016077 - HealthPNX: 2022-03-28
• 07290018016077 - HealthPNX: 2022-03-28