Syngo.CT Vascular Analysis

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K112020 ↗

FDA Product Code

JAK

Device Class

Class II

Regulation

21 CFR Part 892.1750

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Acuson SC2000 Diagnostic Ultrasound System

  Class II

  FDA 510(k) K142628 Active Cleared 10 Oct 2014

• Syngo.VIA

  Class II

  FDA 510(k) K123920 Active Cleared 18 Jan 2013

• Syngo.plaza

  Class II

  FDA 510(k) K093612 Active Cleared 4 Mar 2010

• Syngo Dynamics Version 7.0

  Class II

  FDA 510(k) K081018 Active Cleared 25 Apr 2008

• MOBILETT Impact

  Class II

  FDA 510(k) K231577 Active Cleared 25 Jul 2023

• Syngo Perfusion-CT

  Class II

  FDA 510(k) K033832 Active Cleared 23 Dec 2003

See all devices from Siemens Medi Cal Solutions, Inc. →

• What types of medical imaging studies is this software designed to analyze specifically?

  Syngo.CT Vascular Analysis is specifically designed to analyze computed tomography angiography (CTA) images. It provides vascular-focused tools to visualize, measure, and quantify blood vessels, helping clinicians assess vascular structures for diagnostic purposes or pre-procedural planning.

• Is this software intended for repeated use across multiple imaging sessions, or is it meant to be used once per session?

  This software is intended for single-use per imaging session. It is supplied as a standalone application for immediate vascular-focused analysis on standard medical imaging workstations, rather than being designed for continuous or multi-session deployment.

• How is this software installed and operated, and what kind of workstations does it require?

  Syngo.CT Vascular Analysis is supplied as a standalone application and is intended to operate on standard medical imaging workstations. It does not require additional hardware beyond typical radiology systems, as it is designed to integrate with existing CTA imaging infrastructure for post-processing and analysis.

• What regulatory pathway was followed for FDA clearance, and what does that mean for its intended use?

  The software received FDA 510(k) clearance (K112020) under the Radiology advisory committee (RA) through a traditional review process, with a decision classified as *Substantially Equivalent (SESE)*. This means the FDA determined it is as safe and effective as a legally marketed predicate device for its intended use—post-processing and analysis of CTA images for vascular assessment—without requiring a new clinical trial.