Tomtec Imaging Systems G M B H

FDA Filings

This page includes the latest FDA filings for Tomtec Imaging Systems G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number8043836
FEI Number1000185293
NameTOMTEC Imaging Systems GMBH
Owner & OperatorTOMTEC IMAGING SYSTEMS GMBH
Contact AddressEDISONSTRASSE 6 --
UNTERSCHLEISSHEIM DE-BY Bayern 85716 DE
US Agent
Importing Logistics Registration
ImporterTOMTEC CORPORATION
48466176
Address525 W MONROE ST STE 2360
Chicago, IL 60661 UNITED STATES
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressEDISONSTRASSE 6
UNTERSCHLEISSHEIM Bayern, 85716 DE
Establishment TypeManufacture Medical Device



Registration Number3008349628
FEI Number3008349628
NameTOMTEC CORPORATION
Owner & OperatorTOMTEC IMAGING SYSTEMS GMBH
Contact AddressEDISONSTRASSE 6 --
UNTERSCHLEISSHEIM DE-BY Bayern 85716 DE
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address525 W. Monroe Street Suite 2360
Chicago, IL 60661 US



FDA Filings

Device
Company
DeviceDate
TOMTEC Imaging Systems GmbH
TOMTEC-ARENA2022-01-06
TOMTEC Imaging Systems GmbH
TOMTEC-ARENA 2021-11-29
TOMTEC Imaging Systems GmbH
TOMTEC-ARENA 2021-01-05
TOMTEC Imaging Systems GmbH
TOMTEC-ARENA 2020-08-26
TOMTEC Imaging Systems GmbH
TOMTEC-ARENA2020-08-14
TOMTEC Imaging Systems GMBH
TomTec-Arena2015-10-19
TOMTEC IMAGING SYSTEMS, GMBH
TOMTEC-ARENA TTA22015-02-13
TOMTEC IMAGING SYSTEMS, GMBH
TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA2013-11-25
TOMTEC IMAGING SYSTEMS, GMBH
2D CARDIAC PERFORMANCE ANALYSIS MR 1.02012-04-13
TOMTEC IMAGING SYSTEMS, GMBH
4D LV-ANALYSIS 3.02011-05-24
TOMTEC Imaging Systems GMBH
Image-Arena and Image-Arena Applications2011-04-12
TOMTEC Imaging Systems GMBH
Image-Arena 4.5, Echo-Com 4.5, Image-Com 4.52011-04-12
TOMTEC IMAGING SYSTEMS, GMBH
IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS2011-04-08
TOMTEC IMAGING SYSTEMS, GMBH
4D SONO-SCAN 1.02011-04-07
TOMTEC IMAGING SYSTEMS, GMBH
4D MV-ASSESSMENT 2.02011-01-27
TOMTEC IMAGING SYSTEMS, GMBH
IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.02009-05-22
TOMTEC IMAGING SYSTEMS, GMBH
IMAGE-ARENA APPLICATIONS, MODEL IMAGE-ARENA VA PLATFORM 1.0, 4D LV-ANALYSIS 2.5, 4D LV-ANALYSIS MR 1.02008-10-01
TOMTEC IMAGING SYSTEMS, GMBH
IMAGE-ARENA APPLICATIONS AND RESEARCH-ARENA APPLICATIONS2007-06-20
TOMTEC IMAGING SYSTEMS, GMBH
IMAGE-ARENA AND RESEARCH-ARENA APPLICATIONS2004-04-27
TOMTEC IMAGING SYSTEMS, GMBH
PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING2001-02-14
TOMTEC IMAGING SYSTEMS, GMBH
ECHOCOM, IMAGECOM, DOKUCOM2000-06-16
TOMTEC IMAGING SYSTEMS, GMBH
ECHO VIEW, EASY VIEW, OMNI VIEW1999-11-05
TOMTEC IMAGING SYSTEMS, GMBH
ECHO SCAN, EASY SCAN1999-11-05

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