TOMTEC Imaging Systems GmbH
UNTERSCHLEISSHEIM Bavaria, DE
TOMTEC Imaging Systems GMBH appears in FDA device records in UNTERSCHLEISSHEIM Bavaria, DE. FDA records list 23 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 23 510(k) clearances for TOMTEC Imaging Systems GmbH between 1995 and 2022. The busiest year on record is 2011, with 4. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 1 |
| 1996 | 1 |
| 1999 | 2 |
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 2 |
| 2004 | 1 |
| 2007 | 1 |
| 2008 | 2 |
| 2009 | 1 |
| 2011 | 4 |
| 2012 | 2 |
| 2013 | 1 |
| 2015 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K213544 | TOMTEC-ARENA | QIH | Substantially Equivalent | |
| K201632 | TOMTEC-ARENA | LLZ | Substantially Equivalent | |
| K150122 | TOMTEC-ARENA TTA2 | LLZ | Substantially Equivalent | |
| K132544 | TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA | LLZ | Substantially Equivalent | |
| K122289 | IMAGE-COM 5.0 | LLZ | Substantially Equivalent | |
| K120135 | 2D CARDIAC PERFORMANCE ANALYSIS MR 1.0 | LLZ | Substantially Equivalent | |
| K110746 | 4D LV-ANALYSIS 3.0 | DQK | Substantially Equivalent | |
| K110667 | IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS | LLZ | Substantially Equivalent | |
| K110595 | 4D SONO-SCAN 1.0 | LLZ | Substantially Equivalent | |
| K103782 | 4D MV-ASSESSMENT 2.0 | DQK | Substantially Equivalent | |
| K090461 | IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0 | LLZ | Substantially Equivalent | |
| K083348 | IMAGE-ARENA APPLICATIONS | LLZ | Substantially Equivalent | |
| K082510 | IMAGE-ARENA APPLICATIONS, MODEL IMAGE-ARENA VA PLATFORM 1.0, 4D LV-ANALYSIS 2.5, 4D LV-ANALYSIS MR 1.0 | LLZ | Substantially Equivalent | |
| K071232 | IMAGE-ARENA APPLICATIONS AND RESEARCH-ARENA APPLICATIONS | LLZ | Substantially Equivalent | |
| K040546 | IMAGE-ARENA AND RESEARCH-ARENA APPLICATIONS | LLZ | Substantially Equivalent | |
| 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 | LLZ | Substantially Equivalent | |
| K020561 | SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN | IYO | Substantially Equivalent | |
| K003936 | PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING | IYO | Substantially Equivalent | |
| K001592 | ECHOCOM, IMAGECOM, DOKUCOM | DQK | Substantially Equivalent | |
| K993398 | ECHO VIEW, EASY VIEW, OMNI VIEW | IYO | Substantially Equivalent | |
| K993394 | ECHO SCAN, EASY SCAN | IYO | Substantially Equivalent | |
| K963807 | TOMTEC ECHO-SCAN | IYO | Substantially Equivalent | |
| K950279 | TOMTECP90 | LMB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8043836 | 1000185293 | TOMTEC Imaging Systems GMBH | Freisinger Strasse 9, UNTERSCHLEISSHEIM Bavaria 85716 DE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2496-2020 | TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and communications system. Software Versions and applicable UDI: TTA 1.2 release prior to UDI requirement TTA2.00.01 release prior to UDI requirement TTA2.11.01 release prior to UDI requirement TTA2.11.02 release prior to UDI requirement TTA2.20.01 UDI: (01)04260361440143(11)160429(10)20.01 TTA2.20.10 UDI:(01)04260361440143(11)160809(10)20.10 TTA2.20.13 UDI:(01)04260361440143(11)160922(10)20.13 TTA2.20.14 UDI:(01)04260361440143(11)161028(10)20.14 TTA2.20.15 UDI: (01)04260361440143[11]161207[10]20.15 TTA2.20.16 UDI:(01)04260361440143(11)170127(10)20.16 TTA2.20.18 UDI:(01)04260361440143(11)170622(10)20.18 | The firm discovered a software issue associated with the Image-Com module/clinical application package (CAP) interface for 3D application in the ARENA software, where measurements from one study might be stored to another study. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain