# K223556: DeepCatch

- Pathway: 510(k) (Traditional)
- Applicant: Medical IP Co., Ltd.
- Decided: Jun 16, 2023 after 200 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 9 generations back to K954355 (1995). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191026: Medip Pro, Medical IP Co., Ltd. (2019) Summary page 5.
- K130542: Synapse 3D Lung and Abdomen Analysis, Fujifilm Medical System U.S.A., Inc. (2013) Summary page 5.

## Most influential descendants
- K253944: Data Analysis Facilitation Suite (DAFS) (2026), 0 descendants of its own

## Indications for use
DeepCatch analyzes CT images and auto-segments anatomical structures (skin, bone, muscle, visceral fat, subcutaneous fat, internal organs and central nervous system). Then, its volume and proportions are calculated and provided with the relevant 3D model. By using DeepCatch, it is possible to obtain accurate values for the volume and proportion of each anatomical structures by secondary utilization of CT images obtained for various purposes in the medical field. The type of input data is whole body CT. This device is intended to be used in conjunction with professional clinical judgement. The physician is responsible for inspecting and confirming all results.

Source page: https://510kreport.com/device/K223556
Methodology: https://510kreport.com/methodology