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 Feb 4, 2011 as substantially equivalent to K062163 (Mimvista Corp., 2006) after a 39-day review. Its family tree reaches back 8 generations to 1996. 120 later devices descend from it.
- Decided
- Feb 4, 2011
- Review
- 39 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K954874 (1996). 33 ancestors in all, the oldest K885054 (1989). 120 later devices descend from it, 8 citing it directly.
- Root · 8 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 7 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 6 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 5 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 4 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 3 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 2 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 1 generation backK062163 MimviewerMimvista Corp. · 2006
- This deviceK103785 Mobile MimMim Software, Inc. · 2011
- Descendant · cites it directly · 99 of its ownK112930 Mobile MimMim Software, Inc. · 2011
- Descendant · 2 generations on · 68 of its ownK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
- Descendant · 3 generations on · 67 of its ownK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
- Descendant · 4 generations on · 54 of its ownK180815 MIM - SPECTRA QuantMim Software, Inc. · 2018
- Descendant · 4 generations on · 53 of its ownK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
Showing 5 of 120 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 120 · See all- K112930Mobile MimMim Software, Inc. · 2011 · cites it directly99descendants
- K151913MIM-Thin Client (mobile)Mim Software, Inc. · 2016 · 2 generations on68descendants
- K172218MIM – Y90 DosimetryMim Software, Inc. · 2017 · 3 generations on67descendants
- K180815MIM - SPECTRA QuantMim Software, Inc. · 2018 · 4 generations on54descendants
- K182624MIM - MRT DosimetryMim Software, Inc. · 2018 · 4 generations on53descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −7 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −6 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −5 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −4 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −3 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −2 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −1 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| 0 (this device) | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| +1 | K112930 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| +2 | K151913 | MIM-Thin Client (mobile) | Mim Software, Inc. | 2016 | — |
| +3 | K172218 | MIM – Y90 Dosimetry | Mim Software, Inc. | 2017 | — |
| +4 | K180815 | MIM - SPECTRA Quant | Mim Software, Inc. | 2018 | — |
| +4 | K182624 | MIM - MRT Dosimetry | Mim Software, Inc. | 2018 | — |
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 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 5 | 0 |
| 2015 | 4 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2018 | 6 | 0 |
| 2019 | 8 | 0 |
| 2020 | 7 | 0 |
| 2021 | 12 | 0 |
| 2022 | 11 | 0 |
| 2023 | 13 | 0 |
| 2024 | 9 | 0 |
| 2025 | 18 | 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 21.5 · 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? (1)
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 |
|---|---|---|---|
| * | K062163 | MimviewerSummary page 1…mon Name: Medical Imaging Software Classification Name: System, Imaging Processing, Radiological Predicate Device K062 163 MlMviewer 1.0 MIM Software Inc. (formerly MlMvista Corn.) Intended Use / Indications for Use The Mobile… | 2006 |
What descends from it? (120)
See all 1208 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 1.9 years on median.
- 5 of the 33 ancestors have a recall of any class.
- Of its descendants, K112930 (Mim Software, Inc., 2011) has gone furthest, with 99 descendants of its own.
- 2 other devices also cite its predicate K062163.
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 registration, fusion, and/or display for diagnosis of medical images ftom only the following modalities: SPECT, PET, CT, and MRI.
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/K103785 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103785: Mobile Mim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103785
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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