# K202094: Cardiovascular Suite 4.2.1

- Pathway: 510(k) (Traditional)
- Applicant: Quipu S.R.L
- Decided: Jan 11, 2022 after 532 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- 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 K040227 (2004). 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)
- K033266: Vascular Tools 5, Consisting of Brachial Analyzer 5, Carotid Analyzer 5, Vascular Imager 5 and Integrated Vascular Tools, Medical Imaging Applications, LLC (2004) Summary page 5.

## Indications for use
The Cardiovascular Suite 4.2.1 is a software program that is intended to aid trained healthcare practitioners in the quantitative analysis of vascular ultrasound images in adults, particularly for the measurement of the diameter and its changes on the brachial artery, the diameter and its changes on the carotid artery, the Carotid Intima-Media Thickness, and for carotid plaque analysis.

Source page: https://510kreport.com/device/K202094
Methodology: https://510kreport.com/methodology