# K251964: Mimics Thoracic Planner

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: Mar 12, 2026 after 259 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K924630 (1993). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183105: Mimics Medical, Materialise NV (2019) Summary page 6.

## Indications for use
The Mimics Thoracic Planner is intended to be used as a pre-procedural planning software to review, analyze and plan pulmonary or thoracic procedures based on DICOM-compliant medical images. The Mimics Thoracic Planner allows the clinician to visualize, measure and annotate pre-procedural plan data before and during the procedure, and perform post-op analysis. The Mimics Thoracic Planner allows the clinician to edit pre-procedural plan data before the procedure. The Mimics Thoracic Planner should be used in conjunction with other diagnostic tools and expert clinical judgement.

Source page: https://510kreport.com/device/K251964
Methodology: https://510kreport.com/methodology