# K233217: Mimics Cardiac Planner

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: Feb 12, 2024 after 137 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: 8 generations back to K954678 (1996). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190874: Materialise Mimics Enlight, Materialise NV (2019) Summary page 5.

## Indications for use
Mimics Cardiac Planner is intended to be used as a pre-procedural planning software to screen and plan structural heart and vascular procedures based on DICOM compliant medical images. Mimics Cardiac Planner allows the clinician to visualize, measure, annotate and edit pre-procedural plan data. The software can be used to evaluate the sizing, positioning and delivery pathway of structural heart and vascular devices. Mimics Cardiac Planner should be used in conjunction with other diagnostic tools and expert clinical judgement.

Source page: https://510kreport.com/device/K233217
Methodology: https://510kreport.com/methodology