510(k) · Cleared
ClearedMobile Mim
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 2, 2011 as substantially equivalent to K103785 (Mim Software, Inc., 2011) and 1 other predicate after a 60-day review. Its family tree reaches back 9 generations to 1996. 99 later devices descend from it.
- Decided
- Dec 2, 2011
- Review
- 60 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K954874 (1996). 37 ancestors in all, the oldest K885054 (1989). 99 later devices descend from it, 6 citing it directly.
- Root · 9 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 5 generations between
- 3 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 2 generations backK062163 MimviewerMimvista Corp. · 2006
- 1 generation backK103785 Mobile MimMim Software, Inc. · 2011
- This deviceK112930 Mobile MimMim Software, Inc. · 2011
- Descendant · cites it directly · 68 of its ownK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
- Descendant · 2 generations on · 67 of its ownK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
- Descendant · 3 generations on · 54 of its ownK180815 MIM - SPECTRA QuantMim Software, Inc. · 2018
- Descendant · 3 generations on · 53 of its ownK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
- Descendant · 4 generations on · 30 of its ownK191928 AccuContourXiamen Manteia Technology, Ltd. · 2020
Show all 9 generations
- Root · 9 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 8 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 7 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 6 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 5 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 4 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 3 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 2 generations backK062163 MimviewerMimvista Corp. · 2006
- 1 generation backK103785 Mobile MimMim Software, Inc. · 2011
- This deviceK112930 Mobile MimMim Software, Inc. · 2011
Showing 5 of 99 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 99 · See all- K151913MIM-Thin Client (mobile)Mim Software, Inc. · 2016 · cites it directly68descendants
- K172218MIM – Y90 DosimetryMim Software, Inc. · 2017 · 2 generations on67descendants
- K180815MIM - SPECTRA QuantMim Software, Inc. · 2018 · 3 generations on54descendants
- K182624MIM - MRT DosimetryMim Software, Inc. · 2018 · 3 generations on53descendants
- K191928AccuContourXiamen Manteia Technology, Ltd. · 2020 · 4 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −8 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −7 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −6 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −5 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −4 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −3 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −2 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −1 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| 0 (this device) | K112930 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| +1 | K151913 | MIM-Thin Client (mobile) | Mim Software, Inc. | 2016 | — |
| +2 | K172218 | MIM – Y90 Dosimetry | Mim Software, Inc. | 2017 | — |
| +3 | K180815 | MIM - SPECTRA Quant | Mim Software, Inc. | 2018 | — |
| +3 | K182624 | MIM - MRT Dosimetry | Mim Software, Inc. | 2018 | — |
| +4 | K191928 | AccuContour | Xiamen Manteia Technology, Ltd. | 2020 | — |
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 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 6 | 0 |
| 2019 | 7 | 0 |
| 2020 | 6 | 0 |
| 2021 | 12 | 0 |
| 2022 | 9 | 0 |
| 2023 | 11 | 0 |
| 2024 | 8 | 0 |
| 2025 | 15 | 0 |
| 2026 | 13 | 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 21.6 · 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 |
|---|---|---|---|
| * | K103785 | Mobile MimSummary page 1…mon Name: Medical Imaging Software Classification Name: System, Imaging Processing, Radiological Predicate Device K103785 Mobile MIM MIM Software Inc. K042956 Vision Varian Medical System Intended Us… | 2011 |
| * | K042956 | VisionSummary page 1…Classification Name: System, Imaging Processing, Radiological Predicate Device K103785 Mobile MIM MIM Software Inc. K042956 Vision Varian Medical System Intended Use / Indications for Use The Mobile MIM software program… | 2005 |
What descends from it? (99)
See all 996 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 15 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 6 of the 37 ancestors have a recall of any class.
- Of its descendants, K151913 (Mim Software, Inc., 2016) has gone furthest, with 68 descendants of its own.
- 7 other devices also cite its predicate K103785.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
The Mobile MIM software program is used for the viewing, registration, fusion, and/or display for diagnosis of medical images from the following modalities: SPECT, PET, CT, MRI, X-ray and Ultrasound.
Mobile MIM can be used to review images, contours, DVH, and isodose curves from radiation treatment plans. Mobile MIM can be used to approve these plans.
Mobile MIM provides wireless and portable access to medical images. This device is not intended to replace full workstations and should be used only when there is no access to a workstation.
This device is not to be used for mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112930 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112930: Mobile Mim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112930
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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