# K200810: IPS CaseDesigner

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Oct 8, 2020 after 195 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). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161634: IPS CaseDesigner, Nobel Biocare AB (2016) Summary page 4.

## Most influential descendants
- K230276: TECHFIT DISRP® System (2023), 0 descendants of its own

## Indications for use
IPS CaseDesigner is indicated for use as a software and image segmentation system for the transfer of imaging information from a scanner such as a CT scanner. It is also indicated to support the diagnostic and treatment planning process of craniomaxillofacial procedures. IPS CaseDesigner facilitates the service offering of individualized surgical aids.

Source page: https://510kreport.com/device/K200810
Methodology: https://510kreport.com/methodology