# K200515: syngo.CT Cardiac Planning

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Soultions USA, Inc.
- Decided: Mar 25, 2020 after 23 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: 11 generations back to K954678 (1996). 92 ancestors in all.
No later device cites it as a predicate yet.
0 of 93 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170221: syngo.CT Cardiac Planning, Siemens Healthcare GmbH (2017) Summary page 4.

## Indications for use
syngo.CT Cardiac Planning is an image analysis software package for evaluating contrast enhanced CT images. The software package is designed to support the physician in the qualitative and quantitative analysis of morphology and pathology of vascular and cardiac structures, with the overarching purpose of servicing as input for the planning of cardiovascular procedures.

Source page: https://510kreport.com/device/K200515
Methodology: https://510kreport.com/methodology