510(k) · Cleared
ClearedMim 3.5 (Circa)
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 Oct 31, 2005 as substantially equivalent to K001276 (Syntermed, Inc., 2000) and 4 other predicates after a 62-day review. Its family tree reaches back 5 generations to 1996. 1 of the 373 devices in its family, counting itself, has a Class I recall. 353 later devices descend from it.
- Decided
- Oct 31, 2005
- Review
- 62 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K954874 (1996). 19 ancestors in all, the oldest K885054 (1989). 353 later devices descend from it, 4 citing it directly. 1 of the 373 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 4 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 3 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 2 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 1 generation backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- This deviceK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- Descendant · cites it directly · 350 of its ownK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- Descendant · 2 generations on · 287 of its ownK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
- Descendant · 3 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- Descendant · 2 generations on · 166 of its ownK062163 MimviewerMimvista Corp. · 2006
- Descendant · 3 generations on · 120 of its ownK103785 Mobile MimMim Software, Inc. · 2011
Showing 5 of 353 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…8 generations on · 2025
Most influential descendants
Showing 5 of 353 · See all- K060816Mim 4.0 (NeuroMimvista Corp. · 2006 · cites it directly350descendants
- K071964Mim 4.1 (Seastar)Mimvista Corp. · 2007 · 2 generations on287descendants
- K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 3 generations on200descendants
- K062163MimviewerMimvista Corp. · 2006 · 2 generations on166descendants
- K103785Mobile MimMim Software, Inc. · 2011 · 3 generations on120descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −4 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −3 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −2 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −1 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| 0 (this device) | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| +1 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| +2 | K071964 | Mim 4.1 (Seastar) | Mimvista Corp. | 2007 | 2 |
| +3 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +2 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| +3 | K103785 | 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 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 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 | 17 | 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? (5)
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 |
|---|---|---|---|
| * | K001276 | Medical Image Merge (Mim)Summary page 2…umetric curve and ROI contouring. Substantial Eauivalence MIM 3.5 (CIRCA) is substantially equivalent to; Medical Image Merge (MIM) software (K001276), QGS/QPS software (KO1 1572), 3D-MSPECT Software (K001026), Emory ECTh software (K040141) and Focus Pilot software (K98… | 2000 |
| * | K011572 | Quantitative Gated Spect (QGS), Quantitative Perfusion Spect (QPS) | 2001 |
| * | K001026 | 3D-MspectSummary page 2…MIM 3.5 (CIRCA) is substantially equivalent to; Medical Image Merge (MIM) software (K001276), QGS/QPS software (KO1 1572), 3D-MSPECT Software (K001026), Emory ECTh software (K040141) and Focus Pilot software (K981536). Perfornarnce Dma MIMvista has conducted p… | 2000 |
| * | K040141 | Emory Cardiac Toolbox Version 2.6Summary page 2…stantially equivalent to; Medical Image Merge (MIM) software (K001276), QGS/QPS software (KO1 1572), 3D-MSPECT Software (K001026), Emory ECTh software (K040141) and Focus Pilot software (K981536). Perfornarnce Dma MIMvista has conducted performance and functional testi… | 2004 |
| * | K981535 | Focus Pilot Contouring Workstation Our reading of the summary gave K981536, FDA’s number for Quantech Myoglobin Assay (Hellen Professional Services). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Focus Pilot software”. | 1999 |
What descends from it? (353)
See all 3534 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)
No FDA recall names this device.
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 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- None of the 19 ancestors has a recall.
- Of its descendants, K060816 (Mimvista Corp., 2006) has gone furthest, with 350 descendants of its own.
- 1 other device also cites its predicate K001276.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052379 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052379: Mim 3.5 (Circa).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052379
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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