510(k) · Cleared
ClearedMIM – LesionID Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mim Software, Inc. · LLZ System, Image Processing, Radiological
Cleared on Dec 11, 2025 as substantially equivalent to K243012 (Mim Software, Inc., 2024) and 1 other predicate after a 174-day review. Its family tree reaches back 18 generations to 1996. 1 of the 127 devices in its family, counting itself, has a Class I recall.
- Decided
- Dec 11, 2025
- Review
- 174 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 18 generations to K954874 (1996). 126 ancestors in all, the oldest K871859 (1987). No later device cites it as a predicate yet. 1 of the 127 devices in this family, counting this one, has a Class I recall.
- Root · 18 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 14 generations between
- 3 generations backK220256 MIM-AblationMim Software, Inc. · 2022
- 2 generations backK232862 MIM – Monte Carlo DosimetryMim Software, Inc. · 2024
- 1 generation backK243012 MIM – Symphony HDR FusionMim Software, Inc. · 2024
- This deviceK251883 MIM – LesionID ProMim Software, Inc. · 2025
Show all 18 generations
- Root · 18 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 17 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 16 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 15 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 14 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 13 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 12 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 11 generations backK062163 MimviewerMimvista Corp. · 2006
- 10 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 9 generations backK112930 Mobile MimMim Software, Inc. · 2011
- 8 generations backK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
- 7 generations backK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
- 6 generations backK180815 MIM - SPECTRA QuantMim Software, Inc. · 2018
- 5 generations backK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
- 4 generations backK190379 MIM on LinuxMim Software, Inc. · 2019
- 3 generations backK220256 MIM-AblationMim Software, Inc. · 2022
- 2 generations backK232862 MIM – Monte Carlo DosimetryMim Software, Inc. · 2024
- 1 generation backK243012 MIM – Symphony HDR FusionMim Software, Inc. · 2024
- This deviceK251883 MIM – LesionID ProMim Software, Inc. · 2025
Class I recalls in this family
- K991841 Hawkeye Option for Dual-Head Variable Angle…7 generations back · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −17 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −16 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −15 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −14 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −13 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −12 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −11 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −10 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −9 | K112930 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −8 | K151913 | MIM-Thin Client (mobile) | Mim Software, Inc. | 2016 | — |
| −7 | K172218 | MIM – Y90 Dosimetry | Mim Software, Inc. | 2017 | — |
| −6 | K180815 | MIM - SPECTRA Quant | Mim Software, Inc. | 2018 | — |
| −5 | K182624 | MIM - MRT Dosimetry | Mim Software, Inc. | 2018 | — |
| −4 | K190379 | MIM on Linux | Mim Software, Inc. | 2019 | — |
| −3 | K220256 | MIM-Ablation | Mim Software, Inc. | 2022 | — |
| −2 | K232862 | MIM – Monte Carlo Dosimetry | Mim Software, Inc. | 2024 | — |
| −1 | K243012 | MIM – Symphony HDR Fusion | Mim Software, Inc. | 2024 | — |
| 0 (this device) | K251883 | MIM – LesionID Pro | Mim Software, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 6 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1998 | 6 | 0 |
| 1999 | 3 | 1 |
| 2000 | 11 | 0 |
| 2001 | 8 | 0 |
| 2002 | 7 | 0 |
| 2003 | 6 | 0 |
| 2004 | 9 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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.
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? (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 |
|---|---|---|---|
| * | K243012 | MIM – Symphony HDR FusionSummary page 6…Devices Primary: MIM – Symphony HDR Fusion MIM Software Inc. K243012 | October 23, 2024 Secondary: PET VCAR GE Medical Systems SCS… | 2024 |
| * | K211247 | Pet VcarSummary page 6…2 | October 23, 2024 Secondary: PET VCAR GE Medical Systems SCS K211247 | July 27, 2021 Revision Date: 12/04/2025 1 of 7 Intende… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K991841Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · 7 generations back · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 29 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 36 of the 126 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 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, MR, CR, DX, MG, US, SPECT, PET, and XA as supported by ACR/NEMA DICOM 3.0. MIM assists in the following indications: • Receive, transmit, store, retrieve, display, print, and process medical images and DICOM objects. • Create, display, and print reports…
Read the full statement (385 words)
MIM 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, MR, CR, DX, MG, US, SPECT, PET, and XA as supported by ACR/NEMA DICOM 3.0. MIM 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, staging, treatment planning, monitoring treatment response, and treatment evaluation.
• 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.
• Planning and evaluation of permanent implant brachytherapy procedures (not including radioactive microspheres).
• Calculating absorbed radiation dose as a result of administering a radionuclide.
• Assist with the planning and evaluation of ablation procedures by providing visualization and analysis, including energy zone visualization through the placement of virtual ablation devices validated for inclusion in MIM-Ablation. The software is not intended to predict specific ablation zone volumes or predict ablation success.
When using the device clinically, within the United States, the user should only use FDA approved radiopharmaceuticals. If used with unapproved ones, this device should only be used for research purposes.
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 an 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.
When used for diagnostic purposes, the mobile thin client is not intended to replace a full workstation and should only be used when there is no access to a workstation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251883 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251883: MIM – LesionID Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251883
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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