# K202056: Kinepict Medical Imaging Tool 4.0

- Pathway: 510(k) (Traditional)
- Applicant: Kinepict Health, Ltd.
- Decided: Sep 10, 2021 after 413 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 K010938 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190993: Kinepict Medical Imaging Tool version v2.2, Kinepict Health, Ltd. (2020) Summary page 5.

## Indications for use
Kinepict Medical Imaging Tool version 4.0 (KMIT v4.0) is intended to be used to visualize blood vessel structures by detecting the movement of the contrast bolus during angiography examination and to give the medical experts the option to reduce x-ray dose. The effectively achievable radiation reduction depends on the characteristics of the different cath labs (angiography unit, acquisition protocol, anatomical region) and requires the optimization of locally appled acquisition protocols. The software is intended to be used in addition to, or as a replacement for current DSA imaging. KMIT v4.0 can be deployed on independent workstation hardware for stand-alone diagnostic assessment, post-processing, reporting. It can be configured within a network to send and receive DICOM data. Furthermore, KMIT v4.0 can be deployed on several kinds of angiography systems. It provides solutions in the operating room for image-guided surgery, and image-guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology. KMIT v4.0 can be also combined with fluoroscopic or radiographic systems.

Source page: https://510kreport.com/device/K202056
Methodology: https://510kreport.com/methodology