# K080608: Digital Lightbox

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Apr 17, 2008 after 44 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: 4 generations back to K983410 (1999). 9 ancestors in all.
6 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.
- K042543: Iplan! Digital Templating, Brainlab AG (2005) Summary page 1.
- K070397: Dgscope, Release 1.0, Segami Corporation (2007) Summary page 1.

## Most influential descendants
- K093117: Digital Lightbox (2009), 5 descendants of its own
- 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

## Indications for use
The Digital Lightbox is a system intended for the retrieval and display of medical images from picture archiving and communication systems (PACS), file servers, or removable storage media. It includes functions for image manipulation, 3D reconstruction, basic measurements, and multi-modality image fusion. It is not intended for primary image diagnosis or the review of mammographic images.

Source page: https://510kreport.com/device/K080608
Methodology: https://510kreport.com/methodology