# K223809: PrecisionTAVI (v1.1)

- Pathway: 510(k) (Traditional)
- Applicant: Dasi Simulations
- Decided: May 30, 2023 after 161 days
- Product code: QQI (Interventional Cardiovascular Implant Simulation Software Device)
- Device class: 2
- Regulation: 21 CFR 870.1405
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN200030 (2021). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K214066: FEops HEARTguide, Feops NV (2022) Summary page 4.

## Indications for use
PrecisionTAVI is an optional, non-invasive, post processing software solution that is indicated for patient-specific simulations of Transcatheter Aortic Valve Replacement (TAVR) during procedural planning. The software performs computer simulation to predict post TAVR in vivo valve frame deformation of clinician selected Transcatheter Heart Valve (THV) device types and sizes. The information provided by PrecisionTAVI is intended for use by cardiologists, radiologists, and clinical specialists, and is not intended in any way to eliminate, replace, or substitute for, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition. The clinician receiving the images retains the responsibility for interpreting and validating all information and making all patient treatment decisions. PrecisionTAVI is not intended to replace the simulated device's instructions for use for final TAVR device selection and placement.

Source page: https://510kreport.com/device/K223809
Methodology: https://510kreport.com/methodology