Syntermed, Inc. 333 Sandy Springs Circle NE, Suite 107, Atlanta, GA 30328 | Tel (888) 263-4446 | Fax (888) 216-7511

 

© 2014 Syntermed Inc. All Rights Reserved.  |  For permission, email                              

Emory Toolbox is a trademark of Emory University. AdreView, Xeleris and GE are trademark of General Electric Company.

ImageGuide is a trademark of the American Society of Nuclear Cardiology

Syntermed medical devices are in compliance with FDA (Quality System Records/Pre-Market Notfication 510(k)) and European Union (ISO 13485:2016 FM 670241/CE Mark 696491) regulations.  See IFU for ECTb and NeuroQ.

 

 

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Accepted FDA Pre Market Notification 510(k)’s

July 7, 2014

Cardiac:

Emory Cardiac Toolbox v2.6,  01/22/2004,   K040141

Blood Pool SPECT v1.0, 10/04/2004, K042258

Syntermed Live v 1.0, 03/02/2007, K070089

Emory Cardiac Toolbox v3.1, 07/26/2007, K071503

Emory Cardiac Toolbox v4.0, 02/22/2013, K123646

Emory Cardiac Toolbox v3.2 (AdreView), 06/14/2013, K130902

 

Neurology:

NeuroQ v1.0, 06/17/2004, K0401022

NeuroQ v3.0, 03/14/2008, K072307

NeuroQ v3.6, 05/17/2013, K130451

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