# K252195: ARTICOR planner

- Pathway: 510(k) (Traditional)
- Applicant: Artiness S.R.L
- Decided: Mar 27, 2026 after 256 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 6.

## Indications for use
ARTICOR planner is intended for use as a software interface and image segmentation system to aid in reading and interpreting DICOM compliant images for structural heart and vascular treatment options. For this purpose, ARTICOR planner provides additional visualization and measurement tools to enable the user to screen and plan the procedure. ARTICOR planner should be used in conjunction with other diagnostic tools and expert clinical judgement.

Source page: https://510kreport.com/device/K252195
Methodology: https://510kreport.com/methodology