# K231353: AccuCTP Pro

- Pathway: 510(k) (Special)
- Applicant: ArteryFlow Technology Co., Ltd.
- Decided: Sep 14, 2023 after 127 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: 12 generations back to K896095 (1990). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220663: AccuCTP, ArteryFlow Technology Co., Ltd. (2022) Summary page 4.

## Indications for use
AccuCTP Pro is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing and analysis of brain images. Data and images are acquired through DICOM compliant imaging devices. AccuCTP Pro provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT Perfusion (CTP), which can visualize and analyze dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume.

Source page: https://510kreport.com/device/K231353
Methodology: https://510kreport.com/methodology