The following data is part of a premarket notification filed by Tomtec Imaging Systems, Gmbh with the FDA for Image-arena 4.0 And Ia Applications 2d Cardiac Performance Analysis 1.0.
| Device ID | K090461 |
| 510k Number | K090461 |
| Device Name: | IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | TOMTEC IMAGING SYSTEMS, GMBH EDISONSTRASSE 6 Unterschleissheim, DE D-85716 |
| Contact | Inge Scheidt |
| Correspondent | Inge Scheidt 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 | 2009-02-23 |
| Decision Date | 2009-05-22 |
| Summary: | summary |