# K153705: PROcedure Rehearsal Studio

- Pathway: 510(k) (Special)
- Applicant: 3Dsystems, Simbionix Products
- Decided: Sep 2, 2016 after 254 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: 7 generations back to K924630 (1993). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123269: Procedure Rehearsal Studio, Simbionix, Ltd. (2013) Summary page 4.
- K112387: Procedure Rehearsal Studio (TM), Simbionix, Ltd. (2011) Summary page 4.
- K093269: Procedure Rehearsal Studio, Simbionix, Ltd. (2010) Summary page 4.

## 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 surgical planning

Source page: https://510kreport.com/device/K153705
Methodology: https://510kreport.com/methodology