510(k) · Cleared
ClearedViewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout
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 Oct 16, 2025 as substantially equivalent to K232759 (Brainlab AG, 2024) after a 70-day review. Its family tree reaches back 10 generations to 1990.
- Decided
- Oct 16, 2025
- Review
- 70 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K896095 (1990). 23 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 6 generations between
- 3 generations backK153653 DICOM ViewerBrainlab AG · 2016
- 2 generations backK191014 Elements ViewerBrainlab AG · 2020
- 1 generation backK232759 Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout…Brainlab AG · 2024 · Recalled
- This deviceK252476 Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout…Brainlab AG · 2025
Show all 10 generations
- Root · 10 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 9 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 8 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 7 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 6 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 5 generations backK081304 Alz Web Pacs, Version 1.0Alz, Inc. · 2008
- 4 generations backK130624 CONIGlobalmed · 2013
- 3 generations backK153653 DICOM ViewerBrainlab AG · 2016
- 2 generations backK191014 Elements ViewerBrainlab AG · 2020
- 1 generation backK232759 Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout…Brainlab AG · 2024 · Recalled
- This deviceK252476 Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout…Brainlab AG · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −9 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −8 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −7 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −6 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −5 | K081304 | Alz Web Pacs, Version 1.0 | Alz, Inc. | 2008 | — |
| −4 | K130624 | CONI | Globalmed | 2013 | — |
| −3 | K153653 | DICOM Viewer | Brainlab AG | 2016 | — |
| −2 | K191014 | Elements Viewer | Brainlab AG | 2020 | — |
| −1 | K232759 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements… | Brainlab AG | 2024 | 1 |
| 0 (this device) | K252476 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements… | Brainlab AG | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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 21.5 · 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? (1)
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 |
|---|---|---|---|
| * | K232759 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart…Summary page 5…LLZ Regulation Number 892.2050 Regulatory Class II Panel Radiology Predicate Device(s) Viewer 5.4; K232759 Contact Information Primary Contact Al… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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 35 years and passes through 6 companies; a new generation was cleared every 3.8 years on median.
- 4 of the 23 ancestors have a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 software displays medical images and data. It also includes functions for image review, image manipulation, basic measurements and 3D visualization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252476 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252476: Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252476
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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