Syngo Perfusion-CT

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K033832 ↗

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 is Syngo Perfusion-CT used for?

  Syngo Perfusion-CT is a software package designed to evaluate areas of brain perfusion by calculating cerebral blood flow (CBF), cerebral blood volume (CBV), local bolus timing (including time to start and time to peak), and vascular permeability (blood-brain barrier disturbances) from sets of images reconstructed from continuously acquired CT data after contrast injection.

• How is Syngo Perfusion-CT supplied and what type of device is it?

  Syngo Perfusion-CT is supplied as a software package by Siemens AG Medical Solutions. It is a software-only medical device intended for use in clinical imaging workflows to support perfusion analysis from CT data, not a hardware system or contrast agent.

• What regulatory pathway was used for Syngo Perfusion-CT and when was it cleared?

  Syngo Perfusion-CT received FDA 510(k) clearance (K033832) on December 23, 2003, following a traditional submission process. It was found substantially equivalent to a predicate device and is classified under product code JAK with advisory committee review in Radiology (RA).