| Primary Device ID | 05404028000830 |
| NIH Device Record Key | 579f72aa-b2de-477a-bb25-60502802f4a5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mimics Automatic Algorithms |
| Version Model Number | Mimics Automatic Algorithms CMF Orthognathic CT CB |
| Catalog Number | Mimics Automatic Algorithms CMF Orthognathic CT CB |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 05404028000830 [Primary] |
| LLZ | System, Image Processing, Radiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-09 |
| Device Publish Date | 2026-01-30 |
| 05404028000380 | Mimics Automatic Algorithms Hip CT |
| 05404028000373 | Mimics Automatic Algorithms Shoulder CT |
| 05404028000366 | Mimics Automatic Algorithms CMF CBCT |
| 05404028000342 | Mimics Automatic Algorithms All Bones CT |
| 05404028000663 | Mimics Automatic Algorithms CMF CT |
| 05404028001073 | Mimics Automatic Algorithms Shoulder Arthroplasty CT |
| 05404028001042 | Mimics Automatic Algorithms CMF Reconstruction CT CBCT |
| 05404028000830 | Mimics Automatic Algorithms CMF Orthognathic CT CBCT |