FDA 510(k) Applications Submitted by TOMTEC IMAGING SYSTEMS, GMBH
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K150122 |
01/20/2015 |
TOMTEC-ARENA TTA2 |
TOMTEC IMAGING SYSTEMS, GMBH |
| K132544 |
08/13/2013 |
TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA |
TOMTEC IMAGING SYSTEMS, GMBH |
| K020561 |
02/20/2002 |
SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN |
TOMTEC IMAGING SYSTEMS, GMBH |
| K001592 |
05/23/2000 |
ECHOCOM, IMAGECOM, DOKUCOM |
TOMTEC IMAGING SYSTEMS, GMBH |
| K022824 |
08/26/2002 |
ECHO-VIEW 5.X, EASY-VIEW 2.X, OMNI VIEW 2.X, CARDIO-VIEW 1.X, LV ANALYSIS 1.X & SURGICAL VIEW 1.X |
TOMTEC IMAGING SYSTEMS, GMBH |
| K993394 |
10/08/1999 |
ECHO SCAN, EASY SCAN |
TOMTEC IMAGING SYSTEMS, GMBH |
| K993398 |
10/08/1999 |
ECHO VIEW, EASY VIEW, OMNI VIEW |
TOMTEC IMAGING SYSTEMS, GMBH |
| K003936 |
12/20/2000 |
PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING |
TOMTEC IMAGING SYSTEMS, GMBH |
| K120135 |
01/17/2012 |
2D CARDIAC PERFORMANCE ANALYSIS MR 1.0 |
TOMTEC IMAGING SYSTEMS, GMBH |
| K090461 |
02/23/2009 |
IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0 |
TOMTEC IMAGING SYSTEMS, GMBH |
| K110595 |
03/02/2011 |
4D SONO-SCAN 1.0 |
TOMTEC IMAGING SYSTEMS, GMBH |
| K110667 |
03/09/2011 |
IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS |
TOMTEC IMAGING SYSTEMS, GMBH |
| K110746 |
03/17/2011 |
4D LV-ANALYSIS 3.0 |
TOMTEC IMAGING SYSTEMS, GMBH |
| K071232 |
05/03/2007 |
IMAGE-ARENA APPLICATIONS AND RESEARCH-ARENA APPLICATIONS |
TOMTEC IMAGING SYSTEMS, GMBH |
| K082510 |
08/29/2008 |
IMAGE-ARENA APPLICATIONS, MODEL IMAGE-ARENA VA PLATFORM 1.0, 4D LV-ANALYSIS 2.5, 4D LV-ANALYSIS MR 1.0 |
TOMTEC IMAGING SYSTEMS, GMBH |
| K083348 |
11/13/2008 |
IMAGE-ARENA APPLICATIONS |
TOMTEC IMAGING SYSTEMS, GMBH |
| K103782 |
12/27/2010 |
4D MV-ASSESSMENT 2.0 |
TOMTEC IMAGING SYSTEMS, GMBH |
| K040546 |
03/02/2004 |
IMAGE-ARENA AND RESEARCH-ARENA APPLICATIONS |
TOMTEC IMAGING SYSTEMS, GMBH |
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