MR DRAW

GUDID 03665134000585

A system based on the PROMAP – 3D Prostate Suite range intended to define prostate contour and targets the region of interest on a prostate gland image in anticipation of a fusion with a system compatible with a 3D echography image realized as part of a targeted prostate gland biopsy.

KOELIS

Image segmentation application software

• Primary Device ID: 03665134000585
• NIH Device Record Key: 30bfdfe2-e521-4457-8f66-a2ff1dc41fe9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MR DRAW
• Version Model Number: KURO-4000
• Company DUNS: 290318455
• Company Name: KOELIS
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03665134000578 [Primary]
GS1	03665134000585 [Package]; Contains: 03665134000578; Package: cardboard [1 Units]; In Commercial Distribution

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: 2020-07-31
• Device Publish Date: 2020-07-23

Devices Manufactured by KOELIS

• 03665134000127 - transP - Reusable Guid Perine Grid 14G: 2025-04-25 PERINE range guides are made up of one part fixed on the ultrasound probe, which enables needle guiding. PERINE range guides gu
• 03665134000790 - Reusable guide: 2025-03-18 The device concerned is a metallic guide designed to be plugged on an endocavity ultrasound probe, to guide a linear instrument
• 03665134000851 - 3D Side Fire Endocavity Probe: 2024-08-07
• 03665134000936 - Steady Pro: 2024-06-11 Probe holder for transperineal approach. The Steady Pro range is intended to reliably maintain the position of a transrectal ult
• 03665134000929 - MrDraw: 2023-10-10 A system based on the PROMAP – 3D Prostate Suite range intended to define prostate contour and targets the region of interest
• 03665134000509 - 3D End-Fire Endocavity Probe: 2023-04-13 Invasive 2D/3D endocavity probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam, 3
• 03665134000516 - 3D Side-Fire Endocavity Probe: 2023-04-13 Invasive 2D/3D endocavity probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam, 3
• 03665134000523 - 2D Abdominal Probe: 2023-04-13 Surface 2D probe (Convex) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam for Abdominal, Gy