# K220450: syngo.CT Applications

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Mar 7, 2022 after 18 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: 8 generations back to K954355 (1995). 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)
- K123540: Syngo CT Pulmo 3D, Siemens Medical Systems, Inc. (2013) Summary page 5.

## Most influential descendants
- K232136: syngo.CT Applications (2024), 0 descendants of its own

## Indications for use
syngo.CT Applications is a set of software applications for advanced visualization, measurement, and evaluation for specific body regions. This software package is designed to support the radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice e.g. in the: » Evaluation of perfusion of organs and tumors and myocardial tissue perfusion » Evaluation of bone structures and detection of bone lesions * Evaluation of CT images of the heart * Evaluation of the coronary lesions * Evaluation of the mandible and maxilla » Evaluation of dynamic vessels and extended phase handling » Evaluation of the liver and its intrahepatic vessel structures to identify the vascular territories of sub-vessel systems in the liver * Evaluation of neurovascular structures » Evaluation of the lung parenchyma » Evaluation of non-enhanced Head CT images * Evaluation of vascular lesions

Source page: https://510kreport.com/device/K220450
Methodology: https://510kreport.com/methodology