# K220663: AccuCTP

- Pathway: 510(k) (Traditional)
- Applicant: ArteryFlow Technology Co., Ltd.
- Decided: Nov 22, 2022 after 260 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: 11 generations back to K896095 (1990). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121447: Ischema View Rapid, Ischemaview, Inc. (2013) Summary page 4.

## Most influential descendants
- K231353: AccuCTP Pro (2023), 0 descendants of its own

## Indications for use
AccuCTP 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, 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 provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT Perfusion (CT-P), 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/K220663
Methodology: https://510kreport.com/methodology