# K240385: VINT

- Pathway: 510(k) (Traditional)
- Applicant: Mediimg Corporation
- Decided: Oct 15, 2024 after 250 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: 6 generations back to K942120 (1994). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172803: Infinitt PACS 7.0, Infinitt Healthcare Co., Ltd. (2017) Summary page 6.
- K222854: iTFlow, Cardio Flow Design, Inc. (2023) Summary page 6.

## Indications for use
VINT is a software that allows for the viewing, post-processing, and quantitative evaluation of cerebrovascular MRI data (in DICOM-compliant format). It enables: - Importing DICOM-compliant MR Images. - Quantitative analysis of imported images. - Visualization and analysis of blood flow characteristics of cerebral arteries in MR images. - 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. - Providing the right and left carotid and vertebral arteries wall signal intensity gradient (SIG), an image-based indirect marker for velocity gradient from TOF-MRA. VINT is intended for use with adult (22 years or more) populations who can undergo MRA.

Source page: https://510kreport.com/device/K240385
Methodology: https://510kreport.com/methodology