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Elements Smartbrush 2.5

by Brainlab SE

Elements Smartbrush 2.5 (26200-02C), a radiological PACS-dedicated management software (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Brainlab SE, was cleared under FDA 510(k) K093117 on 11 Dec 2009 and listed in FDA GUDID on 23 Dec 2016 (UDI-DI 04056481006877); the registry lists it as not in commercial distribution (GUDID) as of 23 Oct 2026. FDA recalls on record: 2.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

510(k) K093117

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04056481006877 UDI-DI Date23 Dec 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK093117 Date11 Dec 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K093117 decided 11 Dec 2009 Active
  • FDA GUDID UDI-DI 04056481006877 listed 23 Dec 2016 Listed

Recalls

2 recalls · FDA

    • Terminated Z-0218-2016 FDA Class II initiated 21 Sep 2015

    Potentially incorrectly displayed objects when actively deselecting a fused reference dataset.

    • Terminated Z-2134-2014 FDA Class II initiated 27 Jun 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 2.0, 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

Timeline

4 dated events

  1. Cleared FDA 510(k) K093117
  2. Recall initiated FDA recalls Z-2134-2014
  3. Recall initiated FDA recalls Z-0218-2016
  4. Listed FDA GUDID 04056481006877

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Elements Smartbrush
Generic name
Radiological PACS-dedicated management software
Model / Ref / Catalog
2.5, 26200-02C
Primary DI / UDI-DI
04056481006877
510(k) Number
FDA product code
LLZ
GMDN term
Radiological PACS-dedicated management software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
Not in Commercial Distribution

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

Other devices from Brainlab SE

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Properties

  • Lot / batch number
Other properties (14, all answered No)