Tomtec Imaging Systems GmbH - FDA 510(k) Cleared Devices
21
Total
21
Cleared
0
Denied
FDA 510(k) cleared devices by Tomtec Imaging Systems GmbH Radiology ✕
19 devices
Cleared
Jan 06, 2022
TOMTEC-ARENA
Radiology
59d
Cleared
Aug 14, 2020
TOMTEC-ARENA
Radiology
59d
Cleared
Feb 13, 2015
TOMTEC-ARENA TTA2
Radiology
24d
Cleared
Nov 25, 2013
TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA
Radiology
104d
Cleared
Oct 24, 2012
IMAGE-COM 5.0
Radiology
86d
Cleared
Apr 13, 2012
2D CARDIAC PERFORMANCE ANALYSIS MR 1.0
Radiology
87d
Cleared
May 24, 2011
4D LV-ANALYSIS 3.0
Radiology
68d
Cleared
Apr 08, 2011
IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS
Radiology
30d
Cleared
Apr 07, 2011
4D SONO-SCAN 1.0
Radiology
36d
Cleared
May 22, 2009
IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0
Radiology
88d
Cleared
Dec 23, 2008
IMAGE-ARENA APPLICATIONS
Radiology
40d
Cleared
Oct 01, 2008
IMAGE-ARENA APPLICATIONS, MODEL IMAGE-ARENA VA PLATFORM 1.0, 4D LV-ANALYSIS...
Radiology
33d
Cleared
Jun 20, 2007
IMAGE-ARENA APPLICATIONS AND RESEARCH-ARENA APPLICATIONS
Radiology
48d
Cleared
Apr 27, 2004
IMAGE-ARENA AND RESEARCH-ARENA APPLICATIONS
Radiology
56d
Cleared
Oct 17, 2002
ECHO-VIEW 5.X, EASY-VIEW 2.X, OMNI VIEW 2.X, CARDIO-VIEW 1.X, LV ANALYSIS 1.X...
Radiology
52d
Cleared
May 09, 2002
SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN
Radiology
78d
Cleared
Feb 14, 2001
PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING
Radiology
56d
Cleared
Nov 05, 1999
ECHO SCAN, EASY SCAN
Radiology
28d
Cleared
Nov 05, 1999
ECHO VIEW, EASY VIEW, OMNI VIEW
Radiology
28d