510(k) · Cleared
ClearedAiORTA - Plan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ViTAA Medical Solutions, Inc. · QIH Automated Radiological Image Processing Software
Cleared on Oct 30, 2025 as substantially equivalent to K191585 (Terarecon,Inc., 2019) after a 266-day review. Its family tree reaches back 9 generations to 1991. 1 later device descends from it.
- Decided
- Oct 30, 2025
- Review
- 266 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K913770 (1991). 67 ancestors in all, the oldest K871859 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 5 generations between
- 3 generations backK061214 Aquariusaps ServerTerarecon,Inc. · 2006
- 2 generations backK121916 IntuitionTerarecon,Inc. · 2013 · Recalled
- 1 generation backK191585 iNtuition-Structural Heart ModuleTerarecon,Inc. · 2019
- This deviceK250337 AiORTA - PlanViTAA Medical Solutions, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK254207 AiORTA - Plan v2.0ViTAA Medical Solutions, Inc. · 2026
Show all 9 generations
- Root · 9 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 8 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 7 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 6 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 5 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 4 generations backK041807 Lung Car 1.1Medicsight · 2004
- 3 generations backK061214 Aquariusaps ServerTerarecon,Inc. · 2006
- 2 generations backK121916 IntuitionTerarecon,Inc. · 2013 · Recalled
- 1 generation backK191585 iNtuition-Structural Heart ModuleTerarecon,Inc. · 2019
- This deviceK250337 AiORTA - PlanViTAA Medical Solutions, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K254207AiORTA - Plan v2.0ViTAA Medical Solutions, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −8 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −7 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −6 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −5 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −4 | K041807 | Lung Car 1.1 | Medicsight | 2004 | — |
| −3 | K061214 | Aquariusaps Server | Terarecon,Inc. | 2006 | — |
| −2 | K121916 | Intuition | Terarecon,Inc. | 2013 | 1 |
| −1 | K191585 | iNtuition-Structural Heart Module | Terarecon,Inc. | 2019 | — |
| 0 (this device) | K250337 | AiORTA - Plan | ViTAA Medical Solutions, Inc. | 2025 | — |
| +1 | K254207 | AiORTA - Plan v2.0 | ViTAA Medical Solutions, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 5 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 7 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 6 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 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 |
|---|---|---|---|
| * | K191585 | iNtuition-Structural Heart ModuleSummary page 5…Class II Classification Panel Radiology Predicate Device Trade Name iNtuition-Structural Heart Module 510(k) Number K191585 Regulation Name Medical image management and processing system Common Name System, Image Proces… | 2019 |
| † | K203195 | Simpleware ScanIP Medical | 2021 |
| † | K243158 | TeraRecon Aorta.CT (1.1.0) | 2025 |
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 |
|---|---|---|---|
| K254207 | AiORTA - Plan v2.0 | 2026 | 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 34 years and passes through 7 companies; a new generation was cleared every 4.8 years on median.
- 13 of the 67 ancestors have a recall of any class.
- Of its descendants, K254207 (ViTAA Medical Solutions, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
The AiORTA - Plan tool is an image analysis software tool for volumetric assessment. It provides volumetric visualization and measurements based on 3D reconstruction computed from cardiovascular CTA scans. The software device is intended to provide adjunct information to a licensed healthcare practitioner (HCP) in addition to clinical data and other inputs, as a measurement tool used in assessment of aortic aneurysm, pre-operative evaluation, planning…
Read the full statement (104 words)
The AiORTA - Plan tool is an image analysis software tool for volumetric assessment. It provides volumetric visualization and measurements based on 3D reconstruction computed from cardiovascular CTA scans. The software device is intended to provide adjunct information to a licensed healthcare practitioner (HCP) in addition to clinical data and other inputs, as a measurement tool used in assessment of aortic aneurysm, pre-operative evaluation, planning and sizing for cardiovascular intervention and surgery, and for post-operative evaluation in patients 22 years old and older.
The device is not intended to provide stand-alone diagnosis or suggest an immediate course of action in treatment or patient management.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250337 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250337: AiORTA - Plan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250337
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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