510(k) · Cleared
ClearedArtificial Intelligence Renal Assessment (AIRA) Version 1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aramis Global AI Consultancies, LLC · QIH Automated Radiological Image Processing Software
Cleared on Sep 15, 2026 as substantially equivalent to K222676 (Ceevra, Inc., 2023) after a 117-day review. Its family tree reaches back 11 generations to 1993.
- Decided
- Sep 15, 2026
- Review
- 117 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K924630 (1993). 13 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet.
- Root · 11 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 7 generations between
- 3 generations backK171356 Clarity RevealCeevra, Inc. · 2017
- 2 generations backK173274 Ceevra Reveal 2.0Ceevra, Inc. · 2018
- 1 generation backK222676 Ceevra Reveal 3Ceevra, Inc. · 2023
- This deviceK261677 Artificial Intelligence Renal Assessment (AIRA) Version 1Aramis Global AI Consultancies, LLC · 2026
Show all 11 generations
- Root · 11 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 10 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 9 generations backK033849 Simplant SystemMaterialise NV · 2004
- 8 generations backK073468 MimicsMaterialise NV · 2008
- 7 generations backK093269 Procedure Rehearsal StudioSimbionix, Ltd. · 2010
- 6 generations backK112387 Procedure Rehearsal Studio (TM)Simbionix, Ltd. · 2011
- 5 generations backK123023 Surgery Rehearsal PlatformSurgical Theater, LLC · 2013
- 4 generations backK142107 Echo True 3D ViewerEchopixel, Inc. · 2015 · Recalled
- 3 generations backK171356 Clarity RevealCeevra, Inc. · 2017
- 2 generations backK173274 Ceevra Reveal 2.0Ceevra, Inc. · 2018
- 1 generation backK222676 Ceevra Reveal 3Ceevra, Inc. · 2023
- This deviceK261677 Artificial Intelligence Renal Assessment (AIRA) Version 1Aramis Global AI Consultancies, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −10 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −9 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −8 | K073468 | Mimics | Materialise NV | 2008 | — |
| −7 | K093269 | Procedure Rehearsal Studio | Simbionix, Ltd. | 2010 | — |
| −6 | K112387 | Procedure Rehearsal Studio (TM) | Simbionix, Ltd. | 2011 | — |
| −5 | K123023 | Surgery Rehearsal Platform | Surgical Theater, LLC | 2013 | — |
| −4 | K142107 | Echo True 3D Viewer | Echopixel, Inc. | 2015 | 1 |
| −3 | K171356 | Clarity Reveal | Ceevra, Inc. | 2017 | — |
| −2 | K173274 | Ceevra Reveal 2.0 | Ceevra, Inc. | 2018 | — |
| −1 | K222676 | Ceevra Reveal 3 | Ceevra, Inc. | 2023 | — |
| 0 (this device) | K261677 | Artificial Intelligence Renal Assessment (AIRA) Version 1 | Aramis Global AI Consultancies, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K222676 | Ceevra Reveal 3Summary page 6…device. Device Name Manufacturer 510(k) # Decision Date Ceevra Reveal 3 Ceevra Inc. K222676 04/25/2023 Device Description AIRA operates by using medical imaging data (CT scans) to analyze the size and sha… | 2023 |
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 33 years and passes through 7 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 13 ancestors has a recall of any class.
- 2 other devices also cite its predicate K222676.
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?
Non-invasive processing of CT kidney images using automatic image segmentation and measurement of anatomical structures utilizing artificial intelligence/machine-learning algorithms.
The system automatically calculates the renal parenchymal volume.
AIRA is intended for adult patients who require volumetric measurement of the kidneys for further clinical assessment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K261677 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261677: Artificial Intelligence Renal Assessment (AIRA) Version 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261677
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026