# Elements Smartbrush 2.5

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

- Canonical page: <https://devicerts.com/devices/elements-smartbrush-26200-02c>
- Manufacturer: [Brainlab SE](https://devicerts.com/manufacturers/brainlab-se) (Germany)
- Name in the registry: ELEMENTS SMARTBRUSH 2.5
- Device class: Class II (US FDA)
- FDA product code: LLZ
- GMDN: Radiological PACS-dedicated management software (41670)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 04056481006877 · listed 2016-12-23 · status: Listed (GUDID: not in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K093117 · decision 2009-12-11 · decision SESE · status: Active · from GUDID

## 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

## Identity

- Trade name: ELEMENTS SMARTBRUSH [FDA GUDID (AccessGUDID)]
- Generic name: Radiological PACS-dedicated management software [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: 2.5 [FDA GUDID (AccessGUDID)]; 26200-02C [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 04056481006877 [FDA GUDID (AccessGUDID)]
- 510(k) Number: K093117 [FDA GUDID (AccessGUDID)]
- FDA product code: LLZ [FDA GUDID (AccessGUDID)]
- GMDN term: Radiological PACS-dedicated management software (41670) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 892.2050 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: Not in Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Prescription use: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Elements Smartbrush 2.5, Brainlab SE. deviCERTS medical device catalogue. https://devicerts.com/devices/elements-smartbrush-26200-02c (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/elements-smartbrush-26200-02c.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/elements-smartbrush-26200-02c
- 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.