# K093269: Procedure Rehearsal Studio

- Pathway: 510(k) (Traditional)
- Applicant: Simbionix, Ltd.
- Decided: Aug 20, 2010 after 305 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: 4 generations back to K924630 (1993). 6 ancestors in all.
41 later devices descend from it; 2 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073468: Mimics, Materialise NV (2008) Summary page 1.
- K070226: Cardioct, Shina Systems, Ltd. (2007) Summary page 1.

## Most influential descendants
- K112387: Procedure Rehearsal Studio (TM) (2011), 40 descendants of its own
- K123023: Surgery Rehearsal Platform (2013), 37 descendants of its own
- K142107: Echo True 3D Viewer (2015), 27 descendants of its own
- K171356: Clarity Reveal (2017), 18 descendants of its own
- K173274: Ceevra Reveal 2.0 (2018), 17 descendants of its own

## Indications for use
The PROcedure Rehearsal Studio software is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner to an output file. It is also intended as pre-operative software for simulating/evaluating surgical treatment options.

Source page: https://510kreport.com/device/K093269
Methodology: https://510kreport.com/methodology