# K210726: ImmersiveTouch

- Pathway: 510(k) (Traditional)
- Applicant: Immersivetouch, Inc.
- Decided: Sep 29, 2021 after 202 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.
1 later device descends from it; 1 cites it directly.
0 of 8 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 5.

## Most influential descendants
- K222757: Clarus Viewer (2023), 0 descendants of its own

## Indications for use
ImmersiveTouch is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. ImmersiveTouch is also intended for measuring and treatment planning. ImmersiveTouch output can be used for the fabrication of physical replicas of the output file using traditional or additive manufacturing methods. The physical replicas generated from digital output files are not for diagnostic purpose. ImmersiveTouch should be used in conjunction with expert clinical judgment.

Source page: https://510kreport.com/device/K210726
Methodology: https://510kreport.com/methodology