Quicktome SCI0001

GUDID 09358140000048

Omniscient Neurotechnology Pty Ltd (o8t)

Radiology PACS software

• Primary Device ID: 09358140000048
• NIH Device Record Key: 8434bf51-adf8-473b-b944-3497a8306904
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quicktome
• Version Model Number: 1.3
• Catalog Number: SCI0001
• Company DUNS: 745431891
• Company Name: Omniscient Neurotechnology Pty Ltd (o8t)
• 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: true
• 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	09358140000048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203518

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2023-04-24
• Device Publish Date: 2023-04-14

On-Brand Devices [Quicktome]

• 09358140000017: 1.1
• 09358140000024: 1.2
• 09358140000048: 1.3