Mimics Thoracic Planner Mimics Thoracic Planner

GUDID 05404028000861

Mimics Thoracic Planner

Materialise NV

CAD/CAM software

• Primary Device ID: 05404028000861
• NIH Device Record Key: 85756ed4-07c1-494e-902a-e09034ebdb98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mimics Thoracic Planner
• Version Model Number: Mimics Thoracic Planner
• Catalog Number: Mimics Thoracic Planner
• Company DUNS: 373139427
• Company Name: Materialise NV
• 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: 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	05404028000861 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251964

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: 2026-03-30
• Device Publish Date: 2026-03-20

Devices Manufactured by Materialise NV

• 05404028001158 - Mimics Flow: 2026-03-31 Mimics Flow
• 05404028001172 - SurgiCase Online: 2026-03-31 SurgiCase Online
• 05404028001189 - ProPlan CMF: 2026-03-31 ProPlan CMF Online
• 05404028000861 - Mimics Thoracic Planner: 2026-03-30Mimics Thoracic Planner
• 05404028000861 - Mimics Thoracic Planner: 2026-03-30 Mimics Thoracic Planner
• 05404028000830 - Mimics Automatic Algorithms: 2026-02-09 Mimics Automatic Algorithms CMF Orthognathic CT CBCT
• 05404028001042 - Mimics Automatic Algorithms: 2026-02-09 Mimics Automatic Algorithms CMF Reconstruction CT CBCT
• 05404028001073 - Mimics Automatic Algorithms: 2026-02-09 Mimics Automatic Algorithms Shoulder Arthroplasty CT
• 05404028001110 - SurgiCase Planner: 2025-12-25 SurgiCase Shoulder Planner