Mimics Thoracic Planner— 510(k) K251964
Substantially EquivalentMaterialise NV
FDA 510(k) clearance K251964 for Mimics Thoracic Planner, Substantially Equivalent on 2026-03-12. Applicant: Materialise NV. Device class: 2.
Summary
Materialise's Mimics Thoracic Planner is filed under LLZ, radiological image processing systems. The record doesn't describe the planner beyond its name and that code name.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel. It was a Traditional 510(k).
Materialise filed from Leuven, Belgium. The decision came 259 calendar days after receipt (June 26, 2025 to March 12, 2026).
Clearance details
- Applicant
- Materialise NV
- Product code
- Product code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Leuven, BE
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Adverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.