TOMTEC-ARENA
Automated Radiological Image Processing Software
TOMTEC Imaging Systems GmbH
The following data is part of a premarket notification filed by Tomtec Imaging Systems Gmbh with the FDA for Tomtec-arena.
Pre-market Notification Details
| Device ID | K213544 |
| 510k Number | K213544 |
| Device Name: | TOMTEC-ARENA |
| Classification | Automated Radiological Image Processing Software |
| Applicant | TOMTEC Imaging Systems GmbH Freisinger Strasse 9 Unterschleissheim, DE 85716 |
| Contact | Marc Bergenthal |
| Correspondent | Marc Bergenthal TOMTEC Imaging Systems GmbH Freisinger Strasse 9 Unterschleissheim, DE 85716 |
| Product Code | QIH |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-08 |
| Decision Date | 2022-01-06 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260361440181 | K213544 | 000 |
Trademark Results [TOMTEC-ARENA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TOMTEC-ARENA 86004990 4566739 Live/Registered |
TomTec Imaging Systems GmbH 2013-07-09 |
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