# K112020: Syngo.CT Vascular Analysis

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medi Cal Solutions, Inc.
- Decided: Aug 18, 2011 after 35 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 K954678 (1996). 84 ancestors in all.
99 later devices descend from it; 6 cite it directly.
1 of 184 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043469: Syngo Inspace 4D, Siemens AG Medical Solutions (2005) Summary page 2.
- K092519: Syngo.X, Siemens AG Medical Solutions (2009) Summary page 2.
- K083524: Syngo Dual Energy with Extended Funationally, Siemens Medical Solutions USA, Inc. (2009) Summary page 2.
- K061214: Aquariusaps Server, Terarecon,Inc. (2006) Summary page 2.

## Most influential descendants
- K123920: Syngo.Via (2013), 63 descendants of its own
- K150843: syngo®.via (version VB10A) (2015), 46 descendants of its own
- K163294: syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology (2017), 23 descendants of its own
- K180336: syngo.MR Applications (2018), 21 descendants of its own
- K182904: syngo.MR Applications (2019), 14 descendants of its own

## Indications for use
syngo.CT Vascular Analysis is an image analysis software package for evaluating enhanced CT images. 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), processing tools (bone removal (based both on single energy and Dual Energy), table removal) and evaluation tools (vessel centerline calculation, lumen calculation, stenosis calculation) and reporting tools (lesion location, lesion characteristics and key images), the software package is designed to support the physician in confirming the presence or absence of physician-identified lesions in blood vessels and evaluation, documentation and follow-up of any such lesion. These visualization/processing/evaluation tools allow for characterization of vascular lesions and lesion size over time, helping the physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue.

Source page: https://510kreport.com/device/K112020
Methodology: https://510kreport.com/methodology