510(k) · Cleared
ClearedMimviewer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mimvista Corp. · LLZ System, Image Processing, Radiological
Cleared on Sep 22, 2006 as substantially equivalent to K060816 (Mimvista Corp., 2006) after a 56-day review. Its family tree reaches back 7 generations to 1996. 166 later devices descend from it.
- Decided
- Sep 22, 2006
- Review
- 56 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K954874 (1996). 32 ancestors in all, the oldest K885054 (1989). 166 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 6 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 5 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 4 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 3 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 2 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 1 generation backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- This deviceK062163 MimviewerMimvista Corp. · 2006
- Descendant · cites it directly · 120 of its ownK103785 Mobile MimMim Software, Inc. · 2011
- Descendant · 2 generations on · 99 of its ownK112930 Mobile MimMim Software, Inc. · 2011
- Descendant · 3 generations on · 68 of its ownK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
- Descendant · 4 generations on · 67 of its ownK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
- Descendant · cites it directly · 65 of its ownK070248 VelocityaisVelocity Medical Solutions, LLC · 2007
Showing 5 of 166 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 166 · See all- K103785Mobile MimMim Software, Inc. · 2011 · cites it directly120descendants
- K112930Mobile MimMim Software, Inc. · 2011 · 2 generations on99descendants
- K151913MIM-Thin Client (mobile)Mim Software, Inc. · 2016 · 3 generations on68descendants
- K172218MIM – Y90 DosimetryMim Software, Inc. · 2017 · 4 generations on67descendants
- K070248VelocityaisVelocity Medical Solutions, LLC · 2007 · cites it directly65descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −6 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −5 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −4 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −3 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −2 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −1 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| 0 (this device) | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| +1 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| +2 | K112930 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| +3 | K151913 | MIM-Thin Client (mobile) | Mim Software, Inc. | 2016 | — |
| +4 | K172218 | MIM – Y90 Dosimetry | Mim Software, Inc. | 2017 | — |
| +1 | K070248 | Velocityais | Velocity Medical Solutions, LLC | 2007 | — |
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 |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 6 | 0 |
| 2015 | 5 | 0 |
| 2016 | 6 | 0 |
| 2017 | 5 | 0 |
| 2018 | 9 | 0 |
| 2019 | 11 | 0 |
| 2020 | 9 | 0 |
| 2021 | 17 | 0 |
| 2022 | 16 | 0 |
| 2023 | 16 | 0 |
| 2024 | 12 | 0 |
| 2025 | 21 | 0 |
| 2026 | 18 | 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 |
|---|---|---|---|
| * | K060816 | Mim 4.0 (NeuroSummary page 1…Medical Imaging Software Classification Name: System, Imaging Processing, Radiological Predicate Devices K060816 MIM 4.0 MlMvista Corp. Intended Use MlMviewer is a software package that aids the physic… | 2006 |
What descends from it? (166)
See all 1663 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 10 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 5 of the 32 ancestors have a recall of any class.
- Of its descendants, K103785 (Mim Software, Inc., 2011) has gone furthest, with 120 descendants of its own.
- 5 other devices also cite its predicate K060816.
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 MlMviewer software program is used for the registration, fusion and display of medical images from multiple modalities such as SPECT, PET, CT, and MRI. MlMviewer provides tools for image review, manipulation, and analysis that assist physicians both inside and outside the medical environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062163 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062163: Mimviewer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062163
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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