Syngo Circulation

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K052029 ↗

FDA Product Code

JAK

Device Class

Class II

Regulation

21 CFR Part 892.1750

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Syngo.CT Vascular Analysis

  Class II

  FDA 510(k) K112020 Active Cleared 18 Aug 2011

• 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

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

• What types of imaging systems does Syngo Circulation integrate with, and how does it enhance diagnostic workflows in radiology?

  Syngo Circulation is specifically designed to integrate with CT scanners, enabling the acquisition, processing, and analysis of cardiovascular imaging data. It provides detailed visualization and assessment of cardiac structures and blood flow dynamics, which helps radiologists and interventional specialists in diagnostic evaluation and procedural planning. By streamlining the workflow, it supports more accurate and efficient analysis of cardiac imaging studies.

• Is Syngo Circulation intended for single-use or can it be reused in a clinical setting?

  Syngo Circulation is a reusable, non-sterile software system. Since it operates within a digital imaging workflow and does not involve direct patient contact or sterile procedures, it does not require compliance with single-use medical device standards. This allows for repeated use across multiple patients in radiology departments equipped with CT imaging.

• What regulatory pathway was followed for Syngo Circulation’s FDA clearance, and what does this mean for its use in clinical settings?

  Syngo Circulation received FDA clearance through a 510(k) submission (K052029) with a Substantially Equivalent determination by the Radiology (RA) Advisory Committee. This means the device was evaluated as comparable to a legally marketed predicate device, ensuring it meets established safety and effectiveness standards for cardiovascular imaging software. Clinically, this clearance confirms its suitability for use in radiology departments for diagnostic and interventional planning involving CT-based cardiac imaging.

• Does Syngo Circulation require any special storage conditions, and how is it typically supplied to healthcare facilities?

  As a software-based system, Syngo Circulation is not subject to physical storage constraints like sterile packaging or environmental controls. It is supplied as part of a digital imaging workflow and is integrated into existing CT scanner systems in radiology departments. Since it is non-sterile and reusable, no special storage (e.g., refrigeration or sterile conditions) is required—only proper IT infrastructure and system compatibility with Siemens AG Medical Solutions’ hardware.

• What specific clinical applications does Syngo Circulation support, and how does it benefit cardiovascular diagnostics?

  Syngo Circulation supports the acquisition, processing, and analysis of cardiovascular imaging data from CT scanners, focusing on detailed visualization of cardiac structures and blood flow dynamics. Clinically, this aids in diagnosing cardiovascular conditions, assessing coronary anatomy, and planning interventional procedures like stent placements or valve repairs. By providing enhanced imaging clarity and functional analysis, it improves diagnostic accuracy and procedural outcomes in radiology settings.