510(k) · Cleared
ClearedUltravisual
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emageon Uv, Inc. · LLZ System, Image Processing, Radiological
Cleared on Sep 3, 2004 as substantially equivalent to K012097 (Ultravisual Medical Systems, 2001) after a 39-day review. Its family tree reaches back 4 generations to 1996. 1 later device descends from it.
- Decided
- Sep 3, 2004
- Review
- 39 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K954678 (1996). 7 ancestors in all, the oldest K924178 (1993). 1 later device descends from it, 1 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 backK012097 VortexUltravisual Medical Systems · 2001
- This deviceK042008 UltravisualEmageon Uv, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK053281 Evms (Enterprise Visual Medical System Software)Emageon, Inc. · 2005 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K053281Evms (Enterprise Visual Medical System Software)Emageon, Inc. · 2005 · cites it directly0descendants
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 | K012097 | Vortex | Ultravisual Medical Systems | 2001 | — |
| 0 (this device) | K042008 | Ultravisual | Emageon Uv, Inc. | 2004 | — |
| +1 | K053281 | Evms (Enterprise Visual Medical System Software) | Emageon, Inc. | 2005 | 9 |
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 |
|---|---|---|
| 2005 | 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 |
|---|---|---|---|
| * | K012097 | VortexSummary page 2…Name: Picture Archiving and Communication System Proprietary Name: UltravisualT M (formerly Vortex TM ) Cleared Device(s): Vortex TM , 510(k): K012097 1.5 Device Description and Intended Use Emageon UV, Inc.'s Ultravisuaffl software is integrated client-server software… | 2001 |
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 |
|---|---|---|---|
| K053281 | Evms (Enterprise Visual Medical System Software) | 2005 | 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 8 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K053281 (Emageon, Inc., 2005) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K012097.
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?
Presentation quality mammography images sent via the DICOM standard can be displayed using features that are native to Emageon UV Inc.'s software. Other standard tools include intuitive tools for real-time pan, zoom, window/level and scroll; drag and drop series thumbnails for intuitive navigation; comprehensive set of grayscale and pseudo-color lookup tables; fully configurable magnifying glass; customizable window/level and zoom presets stored by…
Read the full statement (195 words)
Presentation quality mammography images sent via the DICOM standard can be displayed using features that are native to Emageon UV Inc.'s software. Other standard tools include intuitive tools for real-time pan, zoom, window/level and scroll; drag and drop series thumbnails for intuitive navigation; comprehensive set of grayscale and pseudo-color lookup tables; fully configurable magnifying glass; customizable window/level and zoom presets stored by modality and user; rotate images in 90-degree increments; flip image horizontally or vertically; customize display of on-screen user and patient demographics; sharpen, edge and blur filters; key image creation for communicating with other physicians, and multiple display support. Images can be displayed in any configuration or format the user specifies and associates with that specific user's profile. All display protocols and user configurable settings follow the user throughout the enterprise.
Lossy compressed or digitized screen film mammographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a FDA approved monitor that offers at least 5 Mpixel resolutions and other technical specifications reviewed and accepted by FDA.
Intended users of the image distribution system include radiologists, referring physicians, tertiary care physicians, medical technologists, and information technology professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042008 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042008: Ultravisual.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042008
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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