# K181813: ImmersiveView Surgical Plan (IVSP®)

- Pathway: 510(k) (Traditional)
- Applicant: Immersivetouch
- Decided: Jun 9, 2020 after 704 days
- Product code: DZJ (Driver, Wire, And Bone Drill, Manual)
- Device class: 2
- Regulation: 21 CFR 872.4120
- 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). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120956: VSP System, Medical Modeling, Inc. (2012) Summary page 4.

## Indications for use
ImmersiveView Surgical Plan (IVSP®) is intended for use as a software system for the the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the ImmersiveView Surgical Plan (IVSP®) system and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models, surgical splints, and surgical guides for use in maxillofacial surgery. The ImmersiveView Surgical Plan (IVSP®) system is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.

Source page: https://510kreport.com/device/K181813
Methodology: https://510kreport.com/methodology