510(k) · Cleared
ClearedImbio Segmentation Editing Tool software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imbio, LLC · LLZ System, Image Processing, Radiological
Cleared on Mar 16, 2018 as substantially equivalent to K103576 (Mim Software, Inc., 2011) after a 58-day review. Its family tree reaches back 9 generations to 1996.
- Decided
- Mar 16, 2018
- Review
- 58 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K954874 (1996). 53 ancestors in all, the oldest K885054 (1989). No later device cites it as a predicate yet.
- Root · 9 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 5 generations between
- 3 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 2 generations backK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
- 1 generation backK103576 Mim 5.2 (Brachy)Mim Software, Inc. · 2011
- This deviceK180129 Imbio Segmentation Editing Tool softwareImbio, LLC · 2018
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 backK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
- 1 generation backK103576 Mim 5.2 (Brachy)Mim Software, Inc. · 2011
- This deviceK180129 Imbio Segmentation Editing Tool softwareImbio, LLC · 2018
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 | K071964 | Mim 4.1 (Seastar) | Mimvista Corp. | 2007 | 2 |
| −1 | K103576 | Mim 5.2 (Brachy) | Mim Software, Inc. | 2011 | — |
| 0 (this device) | K180129 | Imbio Segmentation Editing Tool software | Imbio, LLC | 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 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 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.
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 |
|---|---|---|---|
| * | K103576 | Mim 5.2 (Brachy)Summary page 4…Predicate Device: Manufacturer: MIM 5.2 (Brachy) Trade name: MIM Software Inc 510(k) Number: K103576 Date Cleared: 18-Feb-2011 Confidential… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 12 of the 53 ancestors have a recall of any class.
- 6 other devices also cite its predicate K103576.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Imbio Segmentation Editing Tool Software is used by trained medical professionals as a tool to modify the contours of segmentation masks produced by Imbio algorithms or to manually create segmentation mask contours. The Segmentation Editing Tool can provide further support to the users of Imbio’s algorithms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180129 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180129: Imbio Segmentation Editing Tool software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180129
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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