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Digital Lightbox

by Brainlab AG 2 variants

510(k) K093117

Digital Lightbox is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Brainlab AG, cleared under FDA 510(k) K093117 on 11 Dec 2009, active as of 22 Oct 2026. 2 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK093117 Date11 Dec 2009ClearedStatusActive

Official records

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

3 dated events

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
LLZ
Device class
Class II
Regulation
21 CFR Part 892.2050
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K093117

5 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K093117
UDI-DISize and differences
Digital Lightbox® 54200B
Brainlab SE
54200B / 54200B04056481001797
Prescription: yes
No longer on the market
Elements Image Fusion 1
Brainlab SE
26217-02A / 104056481000363
Prescription: no
No longer on the market
Elements Image Fusion 2.0
Brainlab SE
26217-02B / 2.004056481000356
Prescription: no
No longer on the market
Elements Smartbrush 1
Brainlab SE
26200-02B / 104056481000431
Prescription: no
No longer on the market
ELEMENTS SMARTBRUSH 2.5
Brainlab SE
26200-02C / 2.504056481006877
Prescription: no
No longer on the market

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

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