510(k) · Cleared
ClearedBrain Viewrx Viewer, Version 1.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kyron Clinical Imaging, Inc. · LLZ System, Image Processing, Radiological
Cleared on Dec 20, 2005 as substantially equivalent to K020546 (Mirada Solutions, Ltd., 2002) and 2 other predicates after a 103-day review. Its family tree reaches back 4 generations to 1996. 5 later devices descend from it.
- Decided
- Dec 20, 2005
- Review
- 103 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K954678 (1996). 10 ancestors in all, the oldest K941223 (1994). 5 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 3 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 2 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 1 generation backK020546 Fusion 7DMirada Solutions, Ltd. · 2002
- This deviceK052467 Brain Viewrx Viewer, Version 1.0Kyron Clinical Imaging, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK063031 Prism View, ModelKyron Clinical Imaging, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK082964 Prism Acquire (Version 1.5), Prism Process (Version 1.5), Prism View…Prism Clinical Imaging, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK060453 Aze VirtualplaceAze, Ltd. · 2006
- Descendant · 2 generations on · 0 of its ownK133521 Aze Phoenix SoftwareAze, Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK122026 Prism Acquire Prism Process Prism ViewPrism Clinical Imaging, Inc. · 2012
Most influential descendants
Showing 5 of 5 · See all- K063031Prism View, ModelKyron Clinical Imaging, Inc. · 2006 · cites it directly2descendants
- K082964Prism Acquire (Version 1.5), Prism Process (Version 1.5), Prism View (Version 2.5)Prism Clinical Imaging, Inc. · 2009 · cites it directly1descendant
- K060453Aze VirtualplaceAze, Ltd. · 2006 · cites it directly1descendant
- K133521Aze Phoenix SoftwareAze, Ltd. · 2014 · 2 generations on0descendants
- K122026Prism Acquire Prism Process Prism ViewPrism Clinical Imaging, Inc. · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −3 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −2 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −1 | K020546 | Fusion 7D | Mirada Solutions, Ltd. | 2002 | — |
| 0 (this device) | K052467 | Brain Viewrx Viewer, Version 1.0 | Kyron Clinical Imaging, Inc. | 2005 | — |
| +1 | K063031 | Prism View, Model | Kyron Clinical Imaging, Inc. | 2006 | — |
| +1 | K082964 | Prism Acquire (Version 1.5), Prism Process (Version 1.5), Prism View (Version… | Prism Clinical Imaging, Inc. | 2009 | — |
| +1 | K060453 | Aze Virtualplace | Aze, Ltd. | 2006 | — |
| +2 | K133521 | Aze Phoenix Software | Aze, Ltd. | 2014 | — |
| +2 | K122026 | Prism Acquire Prism Process Prism View | Prism Clinical Imaging, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 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 21.6 · 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 |
|---|---|---|---|
| * | K020546 | Fusion 7DSummary page 1…e Devices Predicate System Manufacturer Reg. Data Fusion 7D Mirada Solutions Ltd. K020546 Multi-modality registration Oxford Centre for Innov. SE 10/11/2002 workstation software Mill S… | 2002 |
| * | K023130 | Eloquence, Integrated Functional Imaging SystemSummary page 1…Product code LLZ United Kingdom Class II Eloquence Integrated MRI Devices Corp. K023130 Functional Imaging 1515 Paramount Dr. SE 10/11/2002 System Waukes… | 2002 |
| * | K010938 | Syngo Multimodality WorkstationSummary page 1…Product code LNH Class II Syngo® Multimodality Siemens Medical Systems K010938 Workstation 186 Wood Ave. South SE 6/26/2001 Iselin,… | 2001 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 companies; a new generation was cleared every 2.5 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K063031 (Kyron Clinical Imaging, Inc., 2006) has gone furthest, with 2 descendants of its own.
- 8 other devices also cite its predicate K020546.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
BrainViewRxTM provides visualization of functional and physiologic brain imaging data. The software package provides both analysis and viewing capabilities that promote the integration of physiologic and finctional imaging data sets, including blood oxygen level dependent (BOLD) fMRI, magnetic resonance spectroscopy (MRS), and MR diffision including diffusion tensor imaging (DTI). The integration of these data, when interpreted by a trained physician, yields information that may assist in the diagnosis of brain pathology and the planning and monitoring of medical treatments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052467 · printed Nov 3, 2026
Cite this page
510(k) Report. “K052467: Brain Viewrx Viewer, Version 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K052467
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