# K243859: PRAEVAorta®2

- Pathway: 510(k) (Traditional)
- Applicant: Nurea
- Decided: Aug 29, 2025 after 256 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K945512 (1995). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232613: CT Cardiomegaly, Innolitics, LLC (2024) Summary page 6.

## Indications for use
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.

Source page: https://510kreport.com/device/K243859
Methodology: https://510kreport.com/methodology