510(k) · Cleared
ClearedAdvanced Viewer
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 Feb 28, 2014 as substantially equivalent to K130624 (Globalmed, 2013) after a 177-day review. Its family tree reaches back 7 generations to 1990. 1 later device descends from it.
- Decided
- Feb 28, 2014
- Review
- 177 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K896095 (1990). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 6 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 5 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 4 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 3 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 2 generations backK081304 Alz Web Pacs, Version 1.0Alz, Inc. · 2008
- 1 generation backK130624 CONIGlobalmed · 2013
- This deviceK132763 Advanced ViewerBrainlab AG · 2014
- Descendant · cites it directly · 0 of its ownK141199 Quentry Dose ReviewBrainlab AG · 2014
Most influential descendants
Showing 1 of 1 · See all- K141199Quentry Dose ReviewBrainlab AG · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −6 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −5 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −4 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −3 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −2 | K081304 | Alz Web Pacs, Version 1.0 | Alz, Inc. | 2008 | — |
| −1 | K130624 | CONI | Globalmed | 2013 | — |
| 0 (this device) | K132763 | Advanced Viewer | Brainlab AG | 2014 | — |
| +1 | K141199 | Quentry Dose Review | Brainlab AG | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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? (2)
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 |
|---|---|---|---|
| * | K130624 | CONISummary page 1…Advanced Viewer Trade name: Advanced Viewer Common/Classification Picture archiving and communications system Name: Main Predicate Device: CONi (K130624) Secondary Predicate iln(1172 Device: Pa K172 Device classification system, image processing, radiologi… | 2013 |
| * | — | iPlan Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141199 | Quentry Dose Review | 2014 | 0 |
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 24 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K141199 (Brainlab AG, 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K130624.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Advanced Viewer is a web based software for medical professionals that provides doctors with tools for secure online image (DICOM) review including measurement functions and the display of voxel objects.
it is not intended for detailed treatment planning, treatment of patients or the review of manimographic images. htis also not intended to be used on mobile systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132763 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132763: Advanced Viewer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132763
Report an extraction error
Are you the manufacturer?
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