# K140819: Surgical Navigation Advanced Platform

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Theater, LLC
- Decided: Jun 27, 2014 after 87 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.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123023: Surgery Rehearsal Platform, Surgical Theater, LLC (2013) Summary page 1.

## Most influential descendants
- K160584: Surgical Navigation Advanced Platform (SNAP) (2016), 0 descendants of its own

## Indications for use
The Surgical Theater, LLC SNAP is intended for use as a software interface and image segmentation system for the transfer of imaging information from a CT or MR medical scanner to an output file. It is also intended for use in simulating and evaluating surgical treatment options both pre-operatively and intra-operatively with validated systems as identified in the device labeling.

Source page: https://510kreport.com/device/K140819
Methodology: https://510kreport.com/methodology