510(k) · Cleared
ClearedVortex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultravisual Medical Systems · LLZ System, Image Processing, Radiological
Cleared on Jul 12, 2001 as substantially equivalent to K992654 (Voxar Limited, 1999) and 1 other predicate after a 7-day review. Its family tree reaches back 3 generations to 1996. 18 later devices descend from it.
- Decided
- Jul 12, 2001
- Review
- 7 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K954678 (1996). 6 ancestors in all, the oldest K924178 (1993). 18 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 2 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 1 generation backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- This deviceK012097 VortexUltravisual Medical Systems · 2001
- Descendant · cites it directly · 14 of its ownK061421 Erad PacsErad, Inc. · 2006
- Descendant · 2 generations on · 7 of its ownK120995 Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software ProductErad, Inc. · 2012
- Descendant · 3 generations on · 4 of its ownK152977 DG PacsDicom Grid, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 4 of its ownK132799 Clariso PacsClariso, Inc. · 2013
- Descendant · 3 generations on · 3 of its ownK151957 BOX DICOM ViewerBox, Inc. · 2015
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K061421Erad PacsErad, Inc. · 2006 · cites it directly14descendants
- K120995Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software ProductErad, Inc. · 2012 · 2 generations on7descendants
- K152977DG PacsDicom Grid, Inc. · 2016 · 3 generations on4descendants
- K132799Clariso PacsClariso, Inc. · 2013 · 2 generations on4descendants
- K151957BOX DICOM ViewerBox, Inc. · 2015 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −2 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −1 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| 0 (this device) | K012097 | Vortex | Ultravisual Medical Systems | 2001 | — |
| +1 | K061421 | Erad Pacs | Erad, Inc. | 2006 | — |
| +2 | K120995 | Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software Product | Erad, Inc. | 2012 | — |
| +3 | K152977 | DG Pacs | Dicom Grid, Inc. | 2016 | 1 |
| +2 | K132799 | Clariso Pacs | Clariso, Inc. | 2013 | — |
| +3 | K151957 | BOX DICOM Viewer | Box, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K992654 | Plug 'N View 3D, Version 1.0Summary page 2…Proprietary Name: Vortex™ 1.5 1.6 1.7 Substantial Equivalence The UltraVisual Vortex™ software is substantially equivalent to the Voxar Plug ‘n View, K992654 and the AMICAS Web/Intranet Image Server, K970064). Device Description and Intended Use UltraVisual Vortex™ is an integrated c… | 1999 |
| * | K970064 | Amicas Web/Intranet Image ServerSummary page 2…1.7 Substantial Equivalence The UltraVisual Vortex™ software is substantially equivalent to the Voxar Plug ‘n View, K992654 and the AMICAS Web/Intranet Image Server, K970064). Device Description and Intended Use UltraVisual Vortex™ is an integrated client-serversoftware package, which may be marketed… | 1997 |
What descends from it? (18)
See all 184 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 5 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K061421 (Erad, Inc., 2006) has gone furthest, with 14 descendants of its own.
- 15 other devices also cite its predicate K992654.
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?
The system is designed to provide image storage, display, and workflow integration capabilities for healthcare enterprises. The image display architecture provides workgroup diagnostic viewing capabilities for radiologists as well as image reviewing functionality for referring physicians and other clinicians. In addition to traditional 2D image viewing functionality, the image display system provides advanced 3D features including volume rendering and…
Read the full statement (94 words)
The system is designed to provide image storage, display, and workflow integration capabilities for healthcare enterprises. The image display architecture provides workgroup diagnostic viewing capabilities for radiologists as well as image reviewing functionality for referring physicians and other clinicians. In addition to traditional 2D image viewing functionality, the image display system provides advanced 3D features including volume rendering and multi-planar reconstruction designed to function in web-enabled viewers over both local and wide area networks.
Intended users of the image distribution system include radiologists, referring physicians, tertiary care physicians, medical technologists, and information technology professionals.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012097 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012097: Vortex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012097
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026