510(k) · Cleared
ClearedMIM – Y90 Dosimetry
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 Nov 21, 2017 as substantially equivalent to K151913 (Mim Software, Inc., 2016) and 2 other predicates after a 120-day review. Its family tree reaches back 11 generations to 1996. 67 later devices descend from it.
- Decided
- Nov 21, 2017
- Review
- 120 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K954874 (1996). 61 ancestors in all, the oldest K885054 (1989). 67 later devices descend from it, 4 citing it directly.
- Root · 11 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 7 generations between
- 3 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 2 generations backK112930 Mobile MimMim Software, Inc. · 2011
- 1 generation backK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
- This deviceK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
- Descendant · cites it directly · 54 of its ownK180815 MIM - SPECTRA QuantMim Software, Inc. · 2018
- Descendant · cites it directly · 53 of its ownK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
- Descendant · 2 generations on · 30 of its ownK191928 AccuContourXiamen Manteia Technology, Ltd. · 2020
- Descendant · 2 generations on · 14 of its ownK190379 MIM on LinuxMim Software, Inc. · 2019
- Descendant · cites it directly · 8 of its ownK173636 VelocityVarian Medical Systems, Inc. · 2018
Show all 11 generations
- Root · 11 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 10 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 9 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 8 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 7 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 6 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 5 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 4 generations backK062163 MimviewerMimvista Corp. · 2006
- 3 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 2 generations backK112930 Mobile MimMim Software, Inc. · 2011
- 1 generation backK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
- This deviceK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
Showing 5 of 67 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 67 · See all- K180815MIM - SPECTRA QuantMim Software, Inc. · 2018 · cites it directly54descendants
- K182624MIM - MRT DosimetryMim Software, Inc. · 2018 · cites it directly53descendants
- K191928AccuContourXiamen Manteia Technology, Ltd. · 2020 · 2 generations on30descendants
- K190379MIM on LinuxMim Software, Inc. · 2019 · 2 generations on14descendants
- K173636VelocityVarian Medical Systems, Inc. · 2018 · cites it directly8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −10 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −9 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −8 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −7 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −6 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −5 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −4 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −3 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −2 | K112930 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −1 | K151913 | MIM-Thin Client (mobile) | Mim Software, Inc. | 2016 | — |
| 0 (this device) | K172218 | MIM – Y90 Dosimetry | Mim Software, Inc. | 2017 | — |
| +1 | K180815 | MIM - SPECTRA Quant | Mim Software, Inc. | 2018 | — |
| +1 | K182624 | MIM - MRT Dosimetry | Mim Software, Inc. | 2018 | — |
| +2 | K191928 | AccuContour | Xiamen Manteia Technology, Ltd. | 2020 | — |
| +2 | K190379 | MIM on Linux | Mim Software, Inc. | 2019 | — |
| +1 | K173636 | Velocity | Varian Medical Systems, Inc. | 2018 | — |
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 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 4 | 0 |
| 2019 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 9 | 0 |
| 2022 | 7 | 0 |
| 2023 | 8 | 0 |
| 2024 | 8 | 0 |
| 2025 | 11 | 0 |
| 2026 | 11 | 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? (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 |
|---|---|---|---|
| * | K151913 | MIM-Thin Client (mobile)Summary page 5…Number / Product Code: 21 CFR 892.2050 Product Code LLZ Classification Name: System, Imaging Processing, Radiological Predicate Devices K151913 MIM - Thin Client (Mobile) MIM Software Inc. K103576 MIM 5.2 (BRACHY) MIM Software Inc. K033960… | 2016 |
| * | K103576 | Mim 5.2 (Brachy)Summary page 5…Classification Name: System, Imaging Processing, Radiological Predicate Devices K151913 MIM - Thin Client (Mobile) MIM Software Inc. K103576 MIM 5.2 (BRACHY) MIM Software Inc. K033960 OLINDA EXM Vanderbilt University In… | 2011 |
| * | K033960 | Olinda/ExmSummary page 5…sing, Radiological Predicate Devices K151913 MIM - Thin Client (Mobile) MIM Software Inc. K103576 MIM 5.2 (BRACHY) MIM Software Inc. K033960 OLINDA EXM Vanderbilt University Intended Use MIM software is intended for trained medical professi… | 2004 |
What descends from it? (67)
See all 674 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 21 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 13 of the 61 ancestors have a recall of any class.
- Of its descendants, K180815 (Mim Software, Inc., 2018) has gone furthest, with 54 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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, MRI, 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…
Read the full statement (265 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, MRI, 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, 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.
Planning and evaluation of permanent implant brachytherapy procedures (not including radioactive microspheres).
Post-treatment dose calculation and evaluation of permanent Yttrium-90 (Y90) microsphere implants.
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K172218 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172218: MIM – Y90 Dosimetry.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172218
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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