Tomtec Imaging Systems Gmbh
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 23
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2496-2020 | Class II | TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and communications system. | September 23, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K213544 | TOMTEC-ARENA | January 6, 2022 |
| K201632 | TOMTEC-ARENA | August 14, 2020 |
| K150122 | TOMTEC-ARENA TTA2 | February 13, 2015 |
| K132544 | TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA | November 25, 2013 |
| K122289 | IMAGE-COM 5.0 | October 24, 2012 |
| K120135 | 2D CARDIAC PERFORMANCE ANALYSIS MR 1.0 | April 13, 2012 |
| K110746 | 4D LV-ANALYSIS 3.0 | May 24, 2011 |
| K110667 | IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS | April 8, 2011 |
| K110595 | 4D SONO-SCAN 1.0 | April 7, 2011 |
| K103782 | 4D MV-ASSESSMENT 2.0 | January 27, 2011 |
| K090461 | IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0 | May 22, 2009 |
| K083348 | IMAGE-ARENA APPLICATIONS | December 23, 2008 |
| K082510 | IMAGE-ARENA APPLICATIONS, MODEL IMAGE-ARENA VA PLATFORM 1.0, 4D LV-ANALYSIS 2.5, 4D LV-ANALYSIS MR 1 | October 1, 2008 |
| K071232 | IMAGE-ARENA APPLICATIONS AND RESEARCH-ARENA APPLICATIONS | June 20, 2007 |
| K040546 | IMAGE-ARENA AND RESEARCH-ARENA APPLICATIONS | April 27, 2004 |
| K022824 | ECHO-VIEW 5.X, EASY-VIEW 2.X, OMNI VIEW 2.X, CARDIO-VIEW 1.X, LV ANALYSIS 1.X & SURGICAL VIEW 1.X | October 17, 2002 |
| K020561 | SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN | May 9, 2002 |
| K003936 | PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING | February 14, 2001 |
| K001592 | ECHOCOM, IMAGECOM, DOKUCOM | June 16, 2000 |
| K993394 | ECHO SCAN, EASY SCAN | November 5, 1999 |