510(k) · Cleared
ClearedAutoSeg
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ai Medic, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jul 20, 2022 as substantially equivalent to K200973 (Fujifilm Corporaton, 2020) after a 196-day review. Its family tree reaches back 14 generations to 1991. 1 later device descends from it.
- Decided
- Jul 20, 2022
- Review
- 196 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K913770 (1991). 68 ancestors in all, the oldest K871859 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 14 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 10 generations between
- 3 generations backK120636 Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012
- 2 generations backK130383 Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2013
- 1 generation backK200973 Synapse 3D Cardiac ToolsFujifilm Corporaton · 2020
- This deviceK220039 AutoSegAi Medic, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK243158 TeraRecon Aorta.CT (1.1.0)Terarecon,Inc. · 2025
Show all 14 generations
- Root · 14 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 13 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 12 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 11 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 10 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 9 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 8 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 7 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 6 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 5 generations backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- 4 generations backK073156 Qplaque MRMedis Medical Imaging Systems BV · 2008
- 3 generations backK120636 Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012
- 2 generations backK130383 Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2013
- 1 generation backK200973 Synapse 3D Cardiac ToolsFujifilm Corporaton · 2020
- This deviceK220039 AutoSegAi Medic, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −13 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −12 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −11 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −10 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −9 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −8 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −7 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| −6 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| −5 | K071331 | Vitrea Version 4.0 | Vital Images, Inc. | 2007 | 1 |
| −4 | K073156 | Qplaque MR | Medis Medical Imaging Systems BV | 2008 | — |
| −3 | K120636 | Synapse 3D Cardiac Tools | Fujifilm Medical System U.S.A., Inc. | 2012 | — |
| −2 | K130383 | Synapse 3D Cardiac Tools | Fujifilm Medical System U.S.A., Inc. | 2013 | — |
| −1 | K200973 | Synapse 3D Cardiac Tools | Fujifilm Corporaton | 2020 | — |
| 0 (this device) | K220039 | AutoSeg | Ai Medic, Inc. | 2022 | — |
| +1 | K243158 | TeraRecon Aorta.CT (1.1.0) | Terarecon,Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K200973 | Synapse 3D Cardiac ToolsSummary page 5…redicate Device(s) [21 CFR 807.92(a)(3)] The identified predicate devices within this submission are shown as follow: Predicate device ● 510(k) Number: K200973 ● Applicant: FUJIFILM Corporation ● Classification Name: System, Image Processing, Radiological ● T… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243158 | TeraRecon Aorta.CT (1.1.0) | 2025 | 0 |
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 31 years and passes through 8 companies; a new generation was cleared every 11 months on median.
- 10 of the 68 ancestors have a recall of any class.
- Of its descendants, K243158 (Terarecon,Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K200973.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
AutoSeg-H is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. AutoSeg-H accepts DICOM compliant medical images acquired from imaging device (Computed Tomography). AutoSeg-H provides the tools for specific analysis applications which provide custom UI, targeted measurements and reporting functions including: - Coronary Artery Analysis for…
Read the full statement (130 words)
AutoSeg-H is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. AutoSeg-H accepts DICOM compliant medical images acquired from imaging device (Computed Tomography).
AutoSeg-H provides the tools for specific analysis applications which provide custom UI, targeted measurements and reporting functions including:
- Coronary Artery Analysis for CT coronary arteriography images: which is intended for the qualitative and quantitative analysis of coronary arteries.
- Valve Analysis: which is intended for automatic extraction of the heart and aorta regions, automatic detection of the contour of the aorta and valves, measurement of the vicinity of the valves.
- 4-Chamber Analysis: which is intended for automatic extraction of the left atrium, left ventricle, right atrium, and right ventricle from CT.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220039 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220039: AutoSeg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220039
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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