Quantib AI Node

GUDID 08719689791100

Quantib B.V.

Radiology DICOM image processing application software

• Primary Device ID: 08719689791100
• NIH Device Record Key: 803c0054-18aa-4dd0-be9d-fc1a1597b7ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quantib AI Node
• Version Model Number: 2.2
• Company DUNS: 490216247
• Company Name: Quantib B.V.
• 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	08719689791100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200899

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: 2020-12-07
• Device Publish Date: 2020-11-28

On-Brand Devices [Quantib AI Node]

• 08719689791049: 2.0
• 08719689791100: 2.2
• 08719689791124: 2.3
• 08719689791162: 2.4
• 08719689791193: 2.5
• 08719689791247: 2.6
• 08719689791285: No description.