510(k) · Cleared
ClearedPRAEVAorta®2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nurea · QIH Automated Radiological Image Processing Software
Cleared on Aug 29, 2025 as substantially equivalent to K232613 (Innolitics, LLC, 2024) after a 256-day review. Its family tree reaches back 10 generations to 1995.
- Decided
- Aug 29, 2025
- Review
- 256 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K945512 (1995). 19 ancestors in all, the oldest K945428 (1995). No later device cites it as a predicate yet.
- Root · 10 generations backK945512 HRSW Option for CT Twin FlashElscint, Inc. · 1995
- 6 generations between
- 3 generations backK203256 Imbio RV/LV SoftwareImbio, LLC · 2021
- 2 generations backK212624 EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment SystemEver Fortune.Ai, Co., Ltd. · 2022
- 1 generation backK232613 CT CardiomegalyInnolitics, LLC · 2024
- This deviceK243859 PRAEVAorta®2Nurea · 2025
Show all 10 generations
- Root · 10 generations backK945512 HRSW Option for CT Twin FlashElscint, Inc. · 1995
- 9 generations backK970980 Cardiac Scoring for CT ScannersElscint, Inc. · 1997
- 8 generations backK982004 CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage…General Electric Co. · 1998
- 7 generations backK020929 Smartscore 3.5; Smartscore 4.0; Smartscore 4.5GE Medical Systems · 2002
- 6 generations backK072737 CSCS-001A Calcium Scoring PackageToshiba America Medical Systems, In.C · 2007
- 5 generations backK083446 Cardiac Function Analysis, Calcium ScoringZiosoft, Inc. · 2009
- 4 generations backK111373 CT42 Cardiac Computed Tomography (CT) SoftwareCircle Cardiovascular Imaging, Inc. · 2011
- 3 generations backK203256 Imbio RV/LV SoftwareImbio, LLC · 2021
- 2 generations backK212624 EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment SystemEver Fortune.Ai, Co., Ltd. · 2022
- 1 generation backK232613 CT CardiomegalyInnolitics, LLC · 2024
- This deviceK243859 PRAEVAorta®2Nurea · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K945512 | HRSW Option for CT Twin Flash | Elscint, Inc. | 1995 | — |
| −9 | K970980 | Cardiac Scoring for CT Scanners | Elscint, Inc. | 1997 | — |
| −8 | K982004 | CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows | General Electric Co. | 1998 | — |
| −7 | K020929 | Smartscore 3.5; Smartscore 4.0; Smartscore 4.5 | GE Medical Systems | 2002 | — |
| −6 | K072737 | CSCS-001A Calcium Scoring Package | Toshiba America Medical Systems, In.C | 2007 | — |
| −5 | K083446 | Cardiac Function Analysis, Calcium Scoring | Ziosoft, Inc. | 2009 | — |
| −4 | K111373 | CT42 Cardiac Computed Tomography (CT) Software | Circle Cardiovascular Imaging, Inc. | 2011 | — |
| −3 | K203256 | Imbio RV/LV Software | Imbio, LLC | 2021 | — |
| −2 | K212624 | EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System | Ever Fortune.Ai, Co., Ltd. | 2022 | — |
| −1 | K232613 | CT Cardiomegaly | Innolitics, LLC | 2024 | — |
| 0 (this device) | K243859 | PRAEVAorta®2 | Nurea | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 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 |
|---|---|---|---|
| * | K232613 | CT CardiomegalySummary page 6…ss II Review Panel Radiology 3. PREDICATE DEVICE INFORMATION Predicate Device Name CT Cardiomegaly Predicate Device K Number K232613 Common Name Automated Radiological Image Processing Software Product Code QIH Regulatio… | 2024 |
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 30 years and passes through 10 companies; a new generation was cleared every 2.2 years on median.
- None of the 19 ancestors has a recall.
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?
PRAEVAorta®2 is a software intended to be run on its own or as part of another medical device to automatically calculate maximum diameters of anatomical zones from a DICOM CT image containing blood vessels. PRAEVAorta®2 is designed to measure the maximal transverse diameter of vessels and determine the maximal general diameter using a non-adaptative machine learning algorithm. Intended users of the software are aimed to the clinical specialists…
Read the full statement (143 words)
PRAEVAorta®2 is a software intended to be run on its own or as part of another medical device to automatically
calculate maximum diameters of anatomical zones from a DICOM CT image containing blood vessels.
PRAEVAorta®2 is designed to measure the maximal transverse diameter of vessels and determine the maximal general
diameter using a non-adaptative machine learning algorithm.
Intended users of the software are aimed to the clinical specialists, physicians or other licensed practitioners in healthcare
institutions, such as clinics, hospitals, healthcare facilities, residential care facilities and long-term care services. Any
results obtained from the software by an intended user other than a physician must be validated by the physician
responsible of the patient.
The system is suitable for adults. Its results are not intended to be used on a standalone basis for clinical decision making
or otherwise preclude clinical assessment of any disease.
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/K243859 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243859: PRAEVAorta®2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243859
Report an extraction error
Are you the manufacturer?
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