Mimics Thoracic Planner
510(k) K251964
Mimics Thoracic Planner is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Materialise NV, cleared under FDA 510(k) K251964 on 12 Mar 2026, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK251964 | Date12 Mar 2026 | StatusActive |
Official records
- FDA 510(k) database K251964
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K251964
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Mimics Thoracic Planner | Mimics Thoracic Planner / Mimics Thoracic Planner | 05404028000861 | — | On the market |
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