# K222854: iTFlow

- Pathway: 510(k) (Traditional)
- Applicant: Cardio Flow Design, Inc.
- Decided: May 12, 2023 after 233 days
- Product code: LLZ (System, Image Processing, Radiological)
- 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: 4 generations back to K940172 (1994). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141480: CVI42, Circle Cardiovascular Imaging, Inc. (2014) Summary page 4.
- K082628: CMR42 Cardiac Mri Imaging System, 2.1.23, Circle Cardiovascular Imaging, Inc. (2008) Summary page 4.

## Most influential descendants
- K240385: VINT (2024), 0 descendants of its own

## Indications for use
The iTFlow software will be utilized in situations where visualization of blood flow in a heart and its major vessels are required for a cardiac diagnosis. iTFlow allows for the viewing, post-processing, and the quantitative evaluation of cardiovascular MRI data (in DIRECTOR-compliant format) It enables: - The import of DICOM-compliant MR Images. - The support of a clinical diagnosis by the quantitative analysis of the imported images. - Quantitative measurement of the size, area, blood flow, volume and mass of the heart and adjacent vessels. -Advanced correction options such as offset correction, background phase correction, and anti-aliasing. -Data visualization as a graph or output as an image or numerical data. iTFlow software will assist clinicians with proper training in cardiac treatment decision making and in providing a conclusive diagnosis for patients. It is intended to analyze cardiovascular MRI image data, that are acquired via electrocardiogram gated acquisition, gradient echo cine sequence, and phase contrast time-resolved multi-slice sequence, without any-contrast medium for MR angiography. Patient populations are not restricted.

Source page: https://510kreport.com/device/K222854
Methodology: https://510kreport.com/methodology