# K234141: AISAP Cardio V1.0

- Pathway: 510(k) (Traditional)
- Applicant: Aisap
- Decided: Aug 1, 2024 after 216 days
- Product code: POK (Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer)
- Device class: 2
- Regulation: 21 CFR 892.2060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K935595 (1995). 130 ancestors in all.
No later device cites it as a predicate yet.
0 of 131 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201555: EchoGo Pro, Ultromics, Ltd. (2020) Summary page 4.
- K213275: EchoGo Core (2.0), Ultromics Limited (2021) Summary page 4.

## Indications for use
AISAP CARDIO V1.0 is a software platform that automatically processes and analyzes acquired cardiac POCUS images, producing a report with diagnostic assessment and measurements of several key cardiac structural and functional parameters, including: presence of valvular pathology (regurgitations of the mitral, tricuspid, aortic valves and aortic stenosis), and measurements of the Left Ventricle Ejection Fraction (LVEF), right and left ventricular dimensions, right ventricular fractional area change (RV FAC), atrial areas, ascending aorta diameter, and inferior vena cava (IVC) diameter. The device outputs are provided in a report that is intended to support qualified physicians in their analysis and interpretation of adult cardiac POCUS images, using FDA-cleared ultrasound devices. Physicians should be trained and privileged by their organization following education processes and should perform cardiac POCUS according to their specialty professional society clinical guidelines. AISAP CARDIO V1.0 has not been validated for the assessment of congenital heart disease, and/or intra-cardiac lesions (e.g., tumors, thrombi, vegetations), prosthetic valves, and in the presence of ventricular assist devices. AISAP CARDIO V1.0 is indicated for use in adult patients only.

Source page: https://510kreport.com/device/K234141
Methodology: https://510kreport.com/methodology