510(k) · Cleared
ClearedVisio+CD Viewer# KPSCDVE01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Keosys Sas · LLZ System, Image Processing, Radiological
Cleared on Apr 24, 2007 as substantially equivalent to K062163 (Mimvista Corp., 2006) after a 50-day review. Its family tree reaches back 8 generations to 1996. 4 later devices descend from it.
- Decided
- Apr 24, 2007
- Review
- 50 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K954874 (1996). 33 ancestors in all, the oldest K885054 (1989). 4 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 7 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 6 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 5 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 4 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 3 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 2 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 1 generation backK062163 MimviewerMimvista Corp. · 2006
- This deviceK070606 Visio+CD Viewer# KPSCDVE01Keosys Sas · 2007
- Descendant · cites it directly · 3 of its ownK102000 ImagysKeosys Sas · 2010
- Descendant · 2 generations on · 2 of its ownK160334 Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas · 2016
- Descendant · 3 generations on · 1 of its ownK211655 aPROMISEExini Diagnostics AB · 2021
- Descendant · 4 generations on · 0 of its ownK220590 aPROMISE XExini Diagnostics AB · 2022
Most influential descendants
Showing 4 of 4 · See all- K102000ImagysKeosys Sas · 2010 · cites it directly3descendants
- K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas · 2016 · 2 generations on2descendants
- K211655aPROMISEExini Diagnostics AB · 2021 · 3 generations on1descendant
- K220590aPROMISE XExini Diagnostics AB · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −7 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −6 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −5 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −4 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −3 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −2 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −1 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| 0 (this device) | K070606 | Visio+CD Viewer# KPSCDVE01 | Keosys Sas | 2007 | — |
| +1 | K102000 | Imagys | Keosys Sas | 2010 | — |
| +2 | K160334 | Advanced Medical Imaging Software Suite (KSWVWR) | Keosys Sas | 2016 | — |
| +3 | K211655 | aPROMISE | Exini Diagnostics AB | 2021 | — |
| +4 | K220590 | aPROMISE X | Exini Diagnostics AB | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K062163 | MimviewerSummary page 1…er Predicate Device Manufacturer: MIMvista Corp. Predicate Device 510(k) number: K062163 Device Description: Visio+ CD Viewer is a component software which must be burned on a CD-ROM with medical images… | 2006 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102000 | Imagys | 2010 | 3 |
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 11 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 5 of the 33 ancestors have a recall of any class.
- Of its descendants, K102000 (Keosys Sas, 2010) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K062163.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
Visio+ CD Viewer is a software component that is used for viewing medical images stored on a CD-ROM. This software is not meant for primary image interpretation in mammography.
Visio+ CD Viewer is located on the CD-ROM with the medical images. Visio+ CD Viewer provides tools for image review and manipulation which can only be used with the medical images present on the CD-ROM.
Typical users of Visio+ CD Viewer are trained professionals, including physicians and radiologists.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070606 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070606: Visio+CD Viewer# KPSCDVE01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070606
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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