# K160584: Surgical Navigation Advanced Platform (SNAP)

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Theater, LLC
- Decided: Jun 28, 2016 after 119 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 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)
- K140819: Surgical Navigation Advanced Platform, Surgical Theater, LLC (2014) Summary page 4.

## Recalls of this device
- Sep 16, 2025 · Class II · Z-0320-2026: A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer
- Sep 16, 2025 · Class II · Z-0321-2026: A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer
- Sep 16, 2025 · Class II · Z-0323-2026: A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer
- Sep 16, 2025 · Class II · Z-0322-2026: A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer

## 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, MR or X-ray 3D Angiography (XA) 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/K160584
Methodology: https://510kreport.com/methodology