# K123269: Procedure Rehearsal Studio

- Pathway: 510(k) (Special)
- Applicant: Simbionix, Ltd.
- Decided: Jan 29, 2013 after 102 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)
- K112387: Procedure Rehearsal Studio (TM), Simbionix, Ltd. (2011) Summary page 1.

## Most influential descendants
- K153705: PROcedure Rehearsal Studio (2016), 0 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/K123269
Methodology: https://510kreport.com/methodology