# K093117: Digital Lightbox

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Dec 11, 2009 after 70 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K983410 (1999). 10 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053127: IPLAN, Brainlab AG (2006) Summary page 1.
- K080608: Digital Lightbox, Brainlab AG (2008)

## Most influential descendants
- K153653: DICOM Viewer (2016), 4 descendants of its own
- K191014: Elements Viewer (2020), 3 descendants of its own
- K232759: Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout (2024), 1 descendant of its own
- K254265: Helion Viewer Suite (2026), 0 descendants of its own
- K252476: Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout (2025), 0 descendants of its own

## Recalls of this device
- Sep 21, 2015 · Class II · Z-0218-2016: Potentially incorrectly displayed objects when actively deselecting a fused reference dataset.
- Jun 27, 2014 · Class II · Z-2134-2014: The following defects have been identified for data loaded with Patient Data Manager version 2.0 (including subversions 2.0.0, 2.0.1 and 2.0.2): 1) When loading non-square pixel image data with PDM 2.

## Indications for use
The Digital Lightbox is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media. It includes functions for image manipulation, basic measurements and 3D visualization (reconstructions and volume rendering). Features for navigation planning include multi-modality image fusion as well as object and trajectory creation. It is not intended for primary image diagnosis or the review of mammographic images.

Source page: https://510kreport.com/device/K093117
Methodology: https://510kreport.com/methodology