510(k) · Cleared
ClearedVisage Ease Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Visage Imaging GmbH · LLZ System, Image Processing, Radiological
Cleared on Apr 28, 2015 as substantially equivalent to K082269 (Visage Imaging, Inc., 2008) and 1 other predicate after a 260-day review. Its family tree reaches back 10 generations to 1996.
- Decided
- Apr 28, 2015
- Review
- 260 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K954874 (1996). 46 ancestors in all, the oldest K885054 (1989). No later device cites it as a predicate yet.
- Root · 10 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 6 generations between
- 3 generations backK062163 MimviewerMimvista Corp. · 2006
- 2 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 1 generation backK112930 Mobile MimMim Software, Inc. · 2011
- This deviceK142196 Visage Ease ProVisage Imaging GmbH · 2015
Show all 10 generations
- Root · 10 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 9 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 8 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 7 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 6 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 5 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 4 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 3 generations backK062163 MimviewerMimvista Corp. · 2006
- 2 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 1 generation backK112930 Mobile MimMim Software, Inc. · 2011
- This deviceK142196 Visage Ease ProVisage Imaging GmbH · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −9 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −8 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −7 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −6 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −5 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −4 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −3 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −2 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −1 | K112930 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| 0 (this device) | K142196 | Visage Ease Pro | Visage Imaging GmbH | 2015 | — |
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 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 6 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 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? (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 |
|---|---|---|---|
| * | K082269 | Visage Pacs, Version 6.0/CS 3.1Summary page 6…Germany Predicate devices: 1. Device Trade Name: Visage PACS 6.0 / CS 3.1 (Visage 7) Applicant: Visage Imaging, INC. 510(k) No.: K082269 2. Device Trade Name: Mobile MIM (RT) Applicant: MIM Software Inc. 510(k) No.: K112930… | 2008 |
| * | K112930 | Mobile MimSummary page 6…e Imaging, INC. 510(k) No.: K082269 2. Device Trade Name: Mobile MIM (RT) Applicant: MIM Software Inc. 510(k) No.: K112930 The Visage Ease Pro is considered substantial equivalent to the Visage PACS 6.0 / CS 3.1 (K082269), Mobile MIM (RT) (K112930).… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 19 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 6 of the 46 ancestors have a recall of any class.
- 5 other devices also cite its predicate K082269.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
Visage Ease Pro is a mobile client for diagnostic image viewing of radiological images from the following modalities: X-ray, CT, MRI, PET, SPECT, Ultrasound and XA. It is based on the Visage 7 product for distributing, viewing, processing, and archiving medical images within and outside health care environments. Visage Ease Pro must only be used by trained health care professionals. It may support physicians and/or the medical staff by providing mobile…
Read the full statement (166 words)
Visage Ease Pro is a mobile client for diagnostic image viewing of radiological images from the following modalities: X-ray, CT, MRI, PET, SPECT, Ultrasound and XA. It is based on the Visage 7 product for distributing, viewing, processing, and archiving medical images within and outside health care environments.
Visage Ease Pro must only be used by trained health care professionals. It may support physicians and/or the medical staff by providing mobile access to relevant medical images. Any diagnostic or therapeutic decision resides with the doctors and/or the medical staff in their respective area of responsibility.
Visage Ease Pro is not intended to replace full radiologic reading workstations. It must not be used in the context of diagnostic or therapeutic decisions if a radiologic reading workstation with appropriate display hardware is available. The user must make sure that the reading environment complies with any applicable diagnostic requirements and the state-of-the-art.
Visage Ease Pro must not be used for primary image diagnosis in mammography or digital breast tomosynthesis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142196 · printed Nov 3, 2026
Cite this page
510(k) Report. “K142196: Visage Ease Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K142196
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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