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 Number: 8043836
• FEI Number: 1000185293
• Name: TOMTEC Imaging Systems GMBH
• Owner & Operator: TOMTEC IMAGING SYSTEMS GMBH
• Contact Address: EDISONSTRASSE 6 --; UNTERSCHLEISSHEIM DE-BY Bayern 85716 DE
• US Agent:
  • Ron Nolte
  • Philips Healthcare
  • 779 3020649
  • ron.nolte@philips.com
• Importing Logistics Registration:
  • Importer: TOMTEC CORPORATION
  • Address: 525 W MONROE ST STE 2360 ; Chicago, IL 60661 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: EDISONSTRASSE 6 ; UNTERSCHLEISSHEIM Bayern, 85716 DE
• Establishment Type: Manufacture Medical Device

• Registration Number: 3008349628
• FEI Number: 3008349628
• Name: TOMTEC CORPORATION
• Owner & Operator: TOMTEC IMAGING SYSTEMS GMBH
• Contact Address: EDISONSTRASSE 6 --; UNTERSCHLEISSHEIM DE-BY Bayern 85716 DE
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 525 W. Monroe Street Suite 2360; Chicago, IL 60661 US

FDA Filings

Device Company	Device	Date
GUDID 04260361440211 TOMTEC Imaging Systems GmbH	TOMTEC-ARENA	2023-09-14
GUDID 04260361440204 TOMTEC Imaging Systems GmbH	TOMTEC-ARENA	2022-08-10
GUDID 04260361440181 TOMTEC Imaging Systems GmbH	TOMTEC-ARENA	2022-01-31
PMN K213544 TOMTEC Imaging Systems GmbH	TOMTEC-ARENA	2022-01-06
GUDID 04260361440198 TOMTEC Imaging Systems GmbH	TOMTEC-ARENA	2021-11-29
GUDID 04260361440174 TOMTEC Imaging Systems GmbH	TOMTEC-ARENA	2021-01-05
GUDID 04260361440167 TOMTEC Imaging Systems GmbH	TOMTEC-ARENA	2020-08-26
PMN K201632 TOMTEC Imaging Systems GmbH	TOMTEC-ARENA	2020-08-14
PMN K150122 | LLZ TOMTEC Imaging Systems GMBH	TomTec-Arena	2015-10-19
PMN K150122 TOMTEC IMAGING SYSTEMS, GMBH	TOMTEC-ARENA TTA2	2015-02-13
PMN K132544 TOMTEC IMAGING SYSTEMS, GMBH	TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA	2013-11-25
PMN K120135 TOMTEC IMAGING SYSTEMS, GMBH	2D CARDIAC PERFORMANCE ANALYSIS MR 1.0	2012-04-13
PMN K110746 TOMTEC IMAGING SYSTEMS, GMBH	4D LV-ANALYSIS 3.0	2011-05-24
PMN K110667 | LLZ TOMTEC Imaging Systems GMBH	Image-Arena and Image-Arena Applications	2011-04-12
PMN K110667 | LLZ TOMTEC Imaging Systems GMBH	Image-Arena 4.5, Echo-Com 4.5, Image-Com 4.5	2011-04-12
PMN K110667 TOMTEC IMAGING SYSTEMS, GMBH	IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS	2011-04-08
PMN K110595 TOMTEC IMAGING SYSTEMS, GMBH	4D SONO-SCAN 1.0	2011-04-07
PMN K103782 TOMTEC IMAGING SYSTEMS, GMBH	4D MV-ASSESSMENT 2.0	2011-01-27
PMN K090461 TOMTEC IMAGING SYSTEMS, GMBH	IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0	2009-05-22
PMN K082510 TOMTEC IMAGING SYSTEMS, GMBH	IMAGE-ARENA APPLICATIONS, MODEL IMAGE-ARENA VA PLATFORM 1.0, 4D LV-ANALYSIS 2.5, 4D LV-ANALYSIS MR 1.0	2008-10-01
PMN K071232 TOMTEC IMAGING SYSTEMS, GMBH	IMAGE-ARENA APPLICATIONS AND RESEARCH-ARENA APPLICATIONS	2007-06-20
PMN K040546 TOMTEC IMAGING SYSTEMS, GMBH	IMAGE-ARENA AND RESEARCH-ARENA APPLICATIONS	2004-04-27
PMN K020561 TOMTEC IMAGING SYSTEMS, GMBH	SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN	2002-05-09
PMN K003936 TOMTEC IMAGING SYSTEMS, GMBH	PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING	2001-02-14
PMN K001592 TOMTEC IMAGING SYSTEMS, GMBH	ECHOCOM, IMAGECOM, DOKUCOM	2000-06-16
PMN K993398 TOMTEC IMAGING SYSTEMS, GMBH	ECHO VIEW, EASY VIEW, OMNI VIEW	1999-11-05
PMN K993394 TOMTEC IMAGING SYSTEMS, GMBH	ECHO SCAN, EASY SCAN	1999-11-05