510(k) · Cleared
ClearedAiORTA - Plan v2.0
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 Mar 30, 2026 as substantially equivalent to K250337 (ViTAA Medical Solutions, Inc., 2025) after a 91-day review. Its family tree reaches back 10 generations to 1991.
- Decided
- Mar 30, 2026
- Review
- 91 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K913770 (1991). 68 ancestors in all, the oldest K871859 (1987). No later device cites it as a predicate yet.
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations between
- 3 generations backK121916 IntuitionTerarecon,Inc. · 2013 · Recalled
- 2 generations backK191585 iNtuition-Structural Heart ModuleTerarecon,Inc. · 2019
- 1 generation backK250337 AiORTA - PlanViTAA Medical Solutions, Inc. · 2025
- This deviceK254207 AiORTA - Plan v2.0ViTAA Medical Solutions, Inc. · 2026
Show all 10 generations
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 9 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 8 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 7 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 6 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 5 generations backK041807 Lung Car 1.1Medicsight · 2004
- 4 generations backK061214 Aquariusaps ServerTerarecon,Inc. · 2006
- 3 generations backK121916 IntuitionTerarecon,Inc. · 2013 · Recalled
- 2 generations backK191585 iNtuition-Structural Heart ModuleTerarecon,Inc. · 2019
- 1 generation backK250337 AiORTA - PlanViTAA Medical Solutions, Inc. · 2025
- This deviceK254207 AiORTA - Plan v2.0ViTAA Medical Solutions, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −9 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −8 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −7 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −6 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −5 | K041807 | Lung Car 1.1 | Medicsight | 2004 | — |
| −4 | K061214 | Aquariusaps Server | Terarecon,Inc. | 2006 | — |
| −3 | K121916 | Intuition | Terarecon,Inc. | 2013 | 1 |
| −2 | K191585 | iNtuition-Structural Heart Module | Terarecon,Inc. | 2019 | — |
| −1 | K250337 | AiORTA - Plan | ViTAA Medical Solutions, Inc. | 2025 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K250337 | AiORTA - PlanSummary page 5…stem Common Name: Automated Radiological Image Processing Software Class: II Product Code: QIH Predicate Device Trade Name: AiORTA – Plan v1.1 (K250337) Medical Specialty: Radiology Classification: 21 CFR 892.2050 Regulation Name: Medical Image Management and Processing Sy… | 2025 |
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 35 years and passes through 7 companies; a new generation was cleared every 4.8 years on median.
- 13 of the 68 ancestors have a recall of any class.
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. 2026, 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, image analysis, geometric analysis, and pre-operative sizing and planning. 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…
Read the full statement (113 words)
The AiORTA - Plan tool is an image analysis software tool for volumetric assessment, image analysis, geometric analysis, and pre-operative sizing and planning. 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/K254207 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254207: AiORTA - Plan v2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254207
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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