# K231324: DASI Dimensions (V1.0)

- Pathway: 510(k) (Traditional)
- Applicant: Dasi Simulations
- Decided: Jan 8, 2024 after 245 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: 7 generations back to K954678 (1996). 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)
- K153736: 3mensio Workstation, Pie Medical Imaging BV (2016) Summary page 4.

## Indications for use
DASI Dimensions is a standalone, non-invasive, clinical decision support software solution that is intended for use by cardiologists and radiologists in context of the aortic stenosis population. DASI Dimensions provides the end-user with pre-defined images and measurements (diameters, lengths, angles, areas, and perimeters) of cardiovascular structures. The clinician receiving the results retains the responsibility for interpreting and validating all information and making all patient treatment decisions. DASI Dimensions is not intended to replace the clinician's decision or device's instructions for use. DASI Dimensions is prescription use only.

Source page: https://510kreport.com/device/K231324
Methodology: https://510kreport.com/methodology