Mimics Ankle CT

GUDID 05404028000724

Mimics Automatic Algorithms Ankle CT

Materialise NV

CAD/CAM software

• Primary Device ID: 05404028000724
• NIH Device Record Key: f3d161c1-df1c-4ebd-bbe5-5a8d2233fe89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mimics
• Version Model Number: Ankle CT
• Catalog Number: Ankle CT
• 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	05404028000724 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183105

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: 2023-12-26
• Device Publish Date: 2023-12-18

On-Brand Devices [Mimics]

• E314MIMICSMEDICAL0: Mimics Medical
• E314MIMICSINPRINT0: Mimics inPrint
• E314MIMICSAAKNEEMRI0: Mimics Automatic Algorithms Knee MRI
• E314MIMICSAAKNEECT0: Mimics Automatic Algorithms Knee CT
• E314MIMICSAAHEARTCT0: Mimics Automatic Algorithms Heart CT
• E314MIMICSAACMFCT0: Mimics Automatic Algorithms CMF CT
• 05404028000731: Mimics Automatic Algorithms Torso Bone CT
• 05404028000724: Mimics Automatic Algorithms Ankle CT