QP-Prostate

GUDID 08437021468144

Software for quantitative analysis of prostate MRI QP-Prostate® is an image processing software package to be used by trained professionals, including radiologists specialized in prostate imaging, urologists and oncologists. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing and analysis of prostate MR images. Data and images are acquired through DICOM compliant imaging devices and modalities. Patient management decisions should not be based solely on the results of QP-Prostate®. QP-Prostate® does not perform a diagnostic function, but instead allows the users to visualize and analyze DICOM data.

QUIBIM SOCIEDAD LIMITADA.

Radiology DICOM image processing application software

• Primary Device ID: 08437021468144
• NIH Device Record Key: f9400dda-591b-4d65-b62a-c6976151faec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QP-Prostate
• Version Model Number: 1.5
• 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
• Phone: +34 961243225
• Email: support@quibim.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08437021468144 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203582

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: 2024-11-12
• Device Publish Date: 2024-11-04

On-Brand Devices [QP-Prostate]

• 08437021468052: Software for quantitative analysis of prostate MRI QP-Prostate® is an image processing software
• 08437021468144: Software for quantitative analysis of prostate MRI QP-Prostate® is an image processing software