510(k) · Cleared
Recalled · Class II · 2025Mim 4.1 (Seastar)
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 26, 2007 as substantially equivalent to K060816 (Mimvista Corp., 2006) and 2 other predicates after a 72-day review. Its family tree reaches back 7 generations to 1996. 1 of the 334 devices in its family, counting itself, has a Class I recall. 287 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 26, 2007
- Review
- 72 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 7 generations to K954874 (1996). 46 ancestors in all, the oldest K885054 (1989). 287 later devices descend from it, 10 citing it directly. 1 of the 334 devices in this family, counting this one, has a Class I recall.
- 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 deviceK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007
- Descendant · cites it directly · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- Descendant · cites it directly · 79 of its ownK103576 Mim 5.2 (Brachy)Mim Software, Inc. · 2011
- Descendant · 2 generations on · 76 of its ownK101749 Syngo Trued SoftwareSiemens Medical Solutions · 2010
- Descendant · cites it directly · 70 of its ownK101228 Mirada XDMirada Medical, Ltd. · 2010
- Descendant · 2 generations on · 68 of its ownK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
Showing 5 of 287 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…6 generations on · 2025
Most influential descendants
Showing 5 of 287 · See all- K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · cites it directly200descendants
- K103576Mim 5.2 (Brachy)Mim Software, Inc. · 2011 · cites it directly79descendants
- K101749Syngo Trued SoftwareSiemens Medical Solutions · 2010 · 2 generations on76descendants
- K101228Mirada XDMirada Medical, Ltd. · 2010 · cites it directly70descendants
- K151913MIM-Thin Client (mobile)Mim Software, Inc. · 2016 · 2 generations on68descendants
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) | K071964 | Mim 4.1 (Seastar) | Mimvista Corp. | 2007 | — |
| +1 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +1 | K103576 | Mim 5.2 (Brachy) | Mim Software, Inc. | 2011 | — |
| +2 | K101749 | Syngo Trued Software | Siemens Medical Solutions | 2010 | — |
| +1 | K101228 | Mirada XD | Mirada Medical, Ltd. | 2010 | — |
| +2 | K151913 | MIM-Thin Client (mobile) | Mim Software, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 5 | 0 |
| 2011 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 5 | 0 |
| 2014 | 5 | 0 |
| 2015 | 7 | 0 |
| 2016 | 10 | 0 |
| 2017 | 12 | 0 |
| 2018 | 21 | 0 |
| 2019 | 20 | 0 |
| 2020 | 25 | 0 |
| 2021 | 21 | 0 |
| 2022 | 27 | 0 |
| 2023 | 25 | 0 |
| 2024 | 27 | 0 |
| 2025 | 34 | 1 |
| 2026 | 33 | 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? (3)
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 TM 4.0 MIMvista Corp. K061006 IKOEngeloTM IKOEtech, LLC. K043415… | 2006 |
| * | K061006 | IkoengeloSummary page 1…ation Name: System, Imaging Processing, Radiological Predicate Devices K060816 MIM TM 4.0 MIMvista Corp. K061006 IKOEngeloTM IKOEtech, LLC. K043415 CentricityTM GE Medical Systems… | 2006 |
| * | K043415 | Centricity Pacs SystemSummary page 1…iological Predicate Devices K060816 MIM TM 4.0 MIMvista Corp. K061006 IKOEngeloTM IKOEtech, LLC. K043415 CentricityTM GE Medical Systems PACS System Information Technologies In… | 2005 |
What descends from it? (287)
See all 28710 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091373 | Syngo Trued | 2009 | 200 |
| K103576 | Mim 5.2 (Brachy) | 2011 | 79 |
| K101228 | Mirada XD | 2010 | 70 |
| K081076 | Velocityais, Velocity AI, Velocityvx, Velocityrt, V-Response | 2008 | 63 |
| K190379 | MIM on Linux | 2019 | 14 |
| K202700 | ART-Plan | 2021 | 5 |
| K101707 | Fulaccess Model 1.0 | 2010 | 3 |
| K182855 | ProKnow DS | 2019 | 2 |
| K111332 | Clarity Obp System | 2012 | 2 |
| K120851 | Communify Pacs Viewer | 2013 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 19, 2025 | Class II | Z-1267-2025 | Software design | In situations where two images with differing Fields of View (FOV) complete an image fusion, an incorrect, elevated Maximum Standardized Uptake Value (SUV) within MIM Software versions 7.2.0 through 7.2.6.could result. |
| 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 · 6 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 9 of the 46 ancestors have a recall of any class.
- Of its descendants, K091373 (Siemens Medical Solutions USA, Inc., 2009) has gone furthest, with 200 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. 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?
MIM 4.1 (SEASTAR) software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. The medical image modalities include, but are not limited to, CT, MRI, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0. MIM 4.1 (SEASTAR) assists in the following -indications: * Receive, transmit, store, retrieve, display, print, and process medical images and DICOM objects. *…
Read the full statement (253 words)
MIM 4.1 (SEASTAR) software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. The medical image modalities include, but are not limited to, CT, MRI, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0. MIM 4.1 (SEASTAR) assists in the following -indications:
* Receive, transmit, store, retrieve, display, print, and process medical images and DICOM objects.
* Create, display and print reports from medical images.
* Registration, fusion display, and review of medical images for diagnosis, treatment evaluation, and treatment planning.
* Evaluation of cardiac left ventricular function and perfusion, including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction.
* Localization and definition of objects such as tumors and normal tissues in medical images.
* Creation, transformation, and modification of contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management.
* Quantitative and statistical analysis of PET/SPECT brain scans by comparing to other registered PET/SPECT brain scans.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Images that are printed to film must be printed using a FDA-approved printer for the diagnosis of digital mammography images. Mammographic images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images. The software is not to be used for mammography CAD.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071964 · printed Nov 3, 2026
Cite this page
510(k) Report. “K071964: Mim 4.1 (Seastar).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K071964
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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