# K170221: syngo.CT Cardiac Planning

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare GmbH
- Decided: Apr 21, 2017 after 86 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K954678 (1996). 91 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 93 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123585: Syngo, CT Cardiac Function, Siemens Medical Solutions USA, Inc. (2012) Summary page 5.

## Most influential descendants
- K200515: syngo.CT Cardiac Planning (2020), 0 descendants of its own

## Recalls of this device
- Mar 21, 2019 · Class II · Z-1113-2019: There is a potential risk of a wrong measurement in the annulus plane during a TAVI planning procedure. This risk is due to a software issue found in the TAVI algorithm.

## 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 serving as input for planning of cardiovascular procedures.

Source page: https://510kreport.com/device/K170221
Methodology: https://510kreport.com/methodology