QP-Prostate® CAD

GUDID 08437021468168

QP-Prostate® CAD is an artificial intelligence-based Computed Aided Detection and Diagnosis (CADe/CADx) image processing software. QP-Prostate® CAD uses AI-based algorithms trained with pathology data to detect suspicious lesions for clinically significant prostate cancer. The device automatically detects and identifies suspected lesions in the prostate gland based on bi-parametric prostate MRI and provides marks over regions of the images that may contain suspected lesions. There are two possible markers that are provided in the different colors suggesting different levels of suspicion of clinically significant prostate cancer (moderate or high suspicion level).

QUIBIM SOCIEDAD LIMITADA.

MRI image interpretive software

• Primary Device ID: 08437021468168
• NIH Device Record Key: bb147bc5-dbc9-4ca1-909f-a4782e5116f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QP-Prostate® CAD
• Version Model Number: 1.1
• Company DUNS: 464843370
• Company Name: QUIBIM SOCIEDAD LIMITADA.
• 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: true
• 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

Customer Support Contacts

• Phone: +34 961243225
• Email: support@quibim.com
• Phone: +34 961243225
• Email: support@quibim.com
• Phone: +34 961243225
• Email: support@quibim.com
• Phone: +34 961243225
• Email: support@quibim.com
• Phone: +34 961243225
• Email: support@quibim.com
• Phone: +34 961243225
• Email: support@quibim.com
• Phone: +34 961243225
• Email: support@quibim.com
• Phone: +34 961243225
• Email: support@quibim.com
• Phone: +34 961243225
• Email: support@quibim.com
• Phone: +34 961243225
• Email: support@quibim.com
• Phone: +34 961243225
• Email: support@quibim.com
• Phone: +34 961243225
• Email: support@quibim.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08437021468168 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242683

FDA Product Code

• QDQ: Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

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: 2025-05-12
• Device Publish Date: 2025-05-02

On-Brand Devices [QP-Prostate® CAD]

• 08437021468120: QP-Prostate® CAD is an artificial intelligence-based Computed Aided Detection and Diagnosis (CA
• 08437021468168: QP-Prostate® CAD is an artificial intelligence-based Computed Aided Detection and Diagnosis (CA