# Digital Lightbox

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/digital-lightbox-llz>
- Manufacturer: [Brainlab AG](https://devicerts.com/manufacturers/brainlab-ag)
- Name in the registry: DIGITAL LIGHTBOX
- Device class: Class II (US FDA)
- FDA product code: LLZ

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K093117 · decision 2009-12-11 · decision SESE · status: Active

## Recalls

- Z-0218-2016 · Class II · terminated · initiated 2015-09-21: Potentially incorrectly displayed objects when actively deselecting a fused reference dataset.
- Z-2134-2014 · Class II · terminated · initiated 2014-06-27: 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 2.0, the data set is not correctly transferred and displayed in the corresponding Brainlab navigation or planning software. When a data set is loaded, the pixels of the data set are sorted in order to

## Identifiers

- 510(k) Number: K093117 [FDA 510(k)]
- FDA product code: LLZ [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 892.2050 [FDA 510(k)]
- Advisory committee: Radiology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Digital Lightbox, Brainlab AG. deviCERTS medical device catalogue. https://devicerts.com/devices/digital-lightbox-llz (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/digital-lightbox-llz.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/digital-lightbox-llz
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.