# K220910: Medical image processing software

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Deepwise & League of PHD Technology Co., Ltd.
- Decided: Aug 11, 2022 after 135 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K954678 (1996). 89 ancestors in all.
No later device cites it as a predicate yet.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173637: syngo.CT Coronary Analysis; syngo.CT Vascular Analysis, Siemens Medical Solutions USA, Inc. (2018) Summary page 5.

## Indications for use
The DW-CACTAS is a medical image processing software, combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, maximum intensity projection(MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT), curved planar reformation (CPR)), this software is used for post-processing of coronary CT angiography images.

Source page: https://510kreport.com/device/K220910
Methodology: https://510kreport.com/methodology