The following data is part of a premarket notification filed by Tomtec Imaging Systems, Gmbh with the FDA for Tomtec-arena 1.0, Tomtec-arena 3d Echo, Cardio-arena.
| Device ID | K132544 |
| 510k Number | K132544 |
| Device Name: | TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA |
| Classification | System, Image Processing, Radiological |
| Applicant | TOMTEC IMAGING SYSTEMS, GMBH EDISONSTRASSE 6 Unterschleissheim, DE D-85716 |
| Contact | Christine Klein |
| Correspondent | Christine Klein TOMTEC IMAGING SYSTEMS, GMBH EDISONSTRASSE 6 Unterschleissheim, DE D-85716 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-13 |
| Decision Date | 2013-11-25 |
| Summary: | summary |