510(k) · Cleared
Recalled · 2008Mim 4.0 (Neuro
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 May 16, 2006 as substantially equivalent to K052379 (Mimvista Corp., 2005) and 3 other predicates after a 50-day review. Its family tree reaches back 6 generations to 1996. 1 of the 382 devices in its family, counting itself, has a Class I recall. 350 later devices descend from it. It has been recalled once.
- Decided
- May 16, 2006
- Review
- 50 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 6 generations to K954874 (1996). 31 ancestors in all, the oldest K885054 (1989). 350 later devices descend from it, 6 citing it directly. 1 of the 382 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 5 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 4 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 3 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 2 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 1 generation backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- This deviceK060816 Mim 4.0 (NeuroMimvista Corp. · 2006
- Descendant · cites it directly · 287 of its ownK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
- Descendant · 2 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- Descendant · cites it directly · 166 of its ownK062163 MimviewerMimvista Corp. · 2006
- Descendant · 2 generations on · 120 of its ownK103785 Mobile MimMim Software, Inc. · 2011
- Descendant · 3 generations on · 99 of its ownK112930 Mobile MimMim Software, Inc. · 2011
Showing 5 of 350 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…7 generations on · 2025
Most influential descendants
Showing 5 of 350 · See all- K071964Mim 4.1 (Seastar)Mimvista Corp. · 2007 · cites it directly287descendants
- K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 2 generations on200descendants
- K062163MimviewerMimvista Corp. · 2006 · cites it directly166descendants
- K103785Mobile MimMim Software, Inc. · 2011 · 2 generations on120descendants
- K112930Mobile MimMim Software, Inc. · 2011 · 3 generations on99descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −5 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −4 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −3 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −2 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −1 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| 0 (this device) | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | — |
| +1 | K071964 | Mim 4.1 (Seastar) | Mimvista Corp. | 2007 | 2 |
| +2 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +1 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| +2 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| +3 | K112930 | Mobile Mim | Mim Software, Inc. | 2011 | — |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 6 | 0 |
| 2011 | 6 | 0 |
| 2012 | 8 | 0 |
| 2013 | 6 | 0 |
| 2014 | 11 | 0 |
| 2015 | 12 | 0 |
| 2016 | 14 | 0 |
| 2017 | 15 | 0 |
| 2018 | 24 | 0 |
| 2019 | 23 | 0 |
| 2020 | 28 | 0 |
| 2021 | 25 | 0 |
| 2022 | 32 | 0 |
| 2023 | 30 | 0 |
| 2024 | 28 | 0 |
| 2025 | 39 | 1 |
| 2026 | 36 | 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.
1 device in this family has a Class I recall. 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? (4)
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 |
|---|---|---|---|
| * | K052379 | Mim 3.5 (Circa)Summary page 1…Medical Imaging Software Classification Name: System, Imaging Processing, Radiological Predicate Devices K052379 MIM®R 3.5 Ml Mvista Corp. K041022 NeuroQTM Syntermed, Inc. K042863… | 2005 |
| * | K041022 | Neuroq - Pet DPSummary page 1…on Name: System, Imaging Processing, Radiological Predicate Devices K052379 MIM®R 3.5 Ml Mvista Corp. K041022 NeuroQTM Syntermed, Inc. K042863 SceniumrM Siemens Molecular Imaging Ltd.… | 2004 |
| * | K042863 | SceniumSummary page 1…l Predicate Devices K052379 MIM®R 3.5 Ml Mvista Corp. K041022 NeuroQTM Syntermed, Inc. K042863 SceniumrM Siemens Molecular Imaging Ltd. K010726 MirageTM Segami Corp.… | 2004 |
| * | K010726 | Modification to MirageSummary page 1…Ml Mvista Corp. K041022 NeuroQTM Syntermed, Inc. K042863 SceniumrM Siemens Molecular Imaging Ltd. K010726 MirageTM Segami Corp. Intended Use MIM 4.0 (NEURO) is a software package that provides t… | 2001 |
What descends from it? (350)
See all 3506 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 23, 2008 | Not classified | Z-1827-2008 | Software change control | In MIM (4.0.2-4.0.5) and MIM (4.1.0-4.1.2) versions, there is an error that may occur during the calculation of statistics using the SUV Tool or Contour Statistics. It will occur only under the following specific circumstance: A fusion of… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 31 ancestors have a recall of any class.
- Of its descendants, K071964 (Mimvista Corp., 2007) has gone furthest, with 287 descendants of its own.
- 3 other devices also cite its predicate K052379.
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 MIM software program should be used for the registration, fusion and display of medical images from multi-modalities, such as SPECT, PET, CT, and MRI. MIM assists in definition of structures in medical images including tumors, organs, and cardiac left ventricular cavity. MIM aids in the assessment of PET/SPECT brain scans by providing quantitative and statistical comparisons to other registered PET/SPECT brain scans.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060816 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060816: Mim 4.0 (Neuro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060816
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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