Quantib Prostate

GUDID 08719689791117

Quantib B.V.

Radiology DICOM image processing application software

• Primary Device ID: 08719689791117
• NIH Device Record Key: 2996a339-0789-4ff1-9cb4-0bef73f36dc5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quantib Prostate
• Version Model Number: 1.1
• 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	08719689791117 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202501

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: 2020-12-14
• Device Publish Date: 2020-12-04

On-Brand Devices [Quantib Prostate]

• 08719689791056: 1.0
• 08719689791117: 1.1
• 08719689791131: 1.2
• 08719689791155: 1.3
• 08719689791186: 2.0
• 08719689791209: 2.1
• 08719689791223: No description.
• 08719689791230: No description.
• 08719689791278: No description.
• 08719689791292: 3.3