ContourProtégéAI - MR Prostate

GUDID 00850009343093

Contour ProtégéAI is an accessory to MIM software that automatically creates contours on medical images through the use of machine-learning algorithms. It is designed for use in the processing of medical images and operates on Windows, Mac, and Linux computer systems. Contour ProtégéAI is deployed on a remote server using the MIMcloud service for data management and transfer.

MIM SOFTWARE INC.

Radiology PACS software

• Primary Device ID: 00850009343093
• NIH Device Record Key: 9977696a-cde4-4afe-a987-fa5dbeac6d53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ContourProtégéAI - MR Prostate
• Version Model Number: 1.0
• Company DUNS: 136977290
• Company Name: MIM SOFTWARE INC.
• 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	00850009343093 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193252

FDA Product Code

• QKB: Radiological Image Processing Software For Radiation Therapy

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: 2020-10-21
• Device Publish Date: 2020-10-13

Devices Manufactured by MIM SOFTWARE INC.

• 00850009343307 - ContourProtégéAI: 2024-03-28 Contour ProtégéAI is an accessory to MIM software that automatically creates contours on medical images through the use of mac
• 00850009343284 - MIM: 2024-02-16 A medical imaging software package that provides imaging solutions in the fields of radiation oncology, radiology, nuclear medic
• 00860148000894 - Mobile MIM: 2023-10-18 A mobile medical imaging software package that is used for the viewing, registration, fusion, and/or display for diagnosis of me
• 00850009343291 - ContourProtégéAI: 2023-08-28 Contour ProtégéAI is an accessory to MIM software that automatically creates contours on medical images through the use of mac
• 00850009343031 - MIMcloud: 2023-08-21 MIMcloud is a service for institutions, clinicians, and patients provided for the purpose of secure storage and retrieval of med
• 00850009343277 - MIM: 2022-11-17 A medical imaging software package that provides imaging solutions in the fields of radiation oncology, radiology, nuclear medic
• 00850009343178 - ContourProtégéAI - CT Abdomen: 2022-05-24 Contour ProtégéAI is an accessory to MIM software that automatically creates contours on medical images through the use of mac
• 00850009343215 - ContourProtégéAI - CT Lung and Liver: 2022-05-24 Contour ProtégéAI is an accessory to MIM software that automatically creates contours on medical images through the use of mac