510(k) · Cleared
ClearedDigital Lightbox
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainlab AG · LLZ System, Image Processing, Radiological
Cleared on Apr 17, 2008 as substantially equivalent to K053127 (Brainlab AG, 2006) and 2 other predicates after a 44-day review. Its family tree reaches back 4 generations to 1999. 6 later devices descend from it.
- Decided
- Apr 17, 2008
- Review
- 44 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K983410 (1999). 9 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK983410 @ TargetBrainlab AG · 1999
- 3 generations backK020631 IPLANBrainlab AG · 2002
- 2 generations backK041703 IPLAN!Brainlab AG · 2004
- 1 generation backK053127 IPLANBrainlab AG · 2006
- This deviceK080608 Digital LightboxBrainlab AG · 2008
- Descendant · cites it directly · 5 of its ownK093117 Digital LightboxBrainlab AG · 2009 · Recalled
- Descendant · 2 generations on · 4 of its ownK153653 DICOM ViewerBrainlab AG · 2016
- Descendant · 3 generations on · 3 of its ownK191014 Elements ViewerBrainlab AG · 2020
- Descendant · 4 generations on · 1 of its ownK232759 Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout…Brainlab AG · 2024 · Recalled
- Descendant · 4 generations on · 0 of its ownK254265 Helion Viewer SuiteVideomed Srl ( a Baxter Healthcare Corp company) · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K093117Digital LightboxBrainlab AG · 2009 · cites it directly5descendants
- K153653DICOM ViewerBrainlab AG · 2016 · 2 generations on4descendants
- K191014Elements ViewerBrainlab AG · 2020 · 3 generations on3descendants
- K232759Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart…Brainlab AG · 2024 · 4 generations on1descendant
- K254265Helion Viewer SuiteVideomed Srl ( a Baxter Healthcare Corp company) · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K983410 | @ Target | Brainlab AG | 1999 | — |
| −3 | K020631 | IPLAN | Brainlab AG | 2002 | — |
| −2 | K041703 | IPLAN! | Brainlab AG | 2004 | — |
| −1 | K053127 | IPLAN | Brainlab AG | 2006 | — |
| 0 (this device) | K080608 | Digital Lightbox | Brainlab AG | 2008 | — |
| +1 | K093117 | Digital Lightbox | Brainlab AG | 2009 | 2 |
| +2 | K153653 | DICOM Viewer | Brainlab AG | 2016 | — |
| +3 | K191014 | Elements Viewer | Brainlab AG | 2020 | — |
| +4 | K232759 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements… | Brainlab AG | 2024 | 1 |
| +4 | K254265 | Helion Viewer Suite | Videomed Srl ( a Baxter Healthcare Corp company) | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.6 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K053127 | IPLANSummary page 1…ghtbox Common/Classification Name: Digital Lightbox, BrainLAB system, image processing, radiological Predicate Devices: iPlan (K053127) iPlan Hip Templating (K 042543) DGSCOPE, RELEASE 1.0 (K070397) Device Classification Name: System, image processing, radiologic… | 2006 |
| * | K042543 | Iplan! Digital TemplatingSummary page 1…me: Digital Lightbox, BrainLAB system, image processing, radiological Predicate Devices: iPlan (K053127) iPlan Hip Templating (K 042543) DGSCOPE, RELEASE 1.0 (K070397) Device Classification Name: System, image processing, radiological Regulatory Class: Class II I… | 2005 |
| * | K070397 | Dgscope, Release 1.0Summary page 1…inLAB system, image processing, radiological Predicate Devices: iPlan (K053127) iPlan Hip Templating (K 042543) DGSCOPE, RELEASE 1.0 (K070397) Device Classification Name: System, image processing, radiological Regulatory Class: Class II Intended Use: The Digital Lightb… | 2007 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093117 | Digital Lightbox | 2009 | 5 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 1 company; a new generation was cleared every 2.2 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K093117 (Brainlab AG, 2009) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K053127.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080608 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080608: Digital Lightbox.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080608
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026