# K133320: Sicat Function

- Pathway: 510(k) (Traditional)
- Applicant: Sicat GmbH & Co. KG
- Decided: Feb 25, 2014 after 120 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: 6 generations back to K924630 (1993). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103723: Sicat Implant V1.2, Sicat GmbH & Co. KG (2011) Summary page 1.
- K033849: Simplant System, Materialise NV (2004) Summary page 1.
- K053592: Simplant DR. James, Materialise NV (2006) Summary page 1.
- K081402: Simplant Ortho ; Vistadent 3D, Materialise Dental NV (2008) Summary page 1.

## Most influential descendants
- K183676: DentiqAir (2019), 0 descendants of its own
- K152661: HICAT Air (2015), 0 descendants of its own

## Indications for use
SICAT Function is a software application for the visualization and segmentation of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or CUCT scanners. It is also used as a software system to aid qualified dental professionals with the evaluation of dental treatment options. The dental professionals' planning data may be exported from SICAT Function and used as input data for CAD or Rapid Prototyping Systems.

Source page: https://510kreport.com/device/K133320
Methodology: https://510kreport.com/methodology