The following data is part of a premarket notification filed by Tomtec Imaging Systems, Gmbh with the FDA for Image-arena And Research-arena Applications.
| Device ID | K040546 |
| 510k Number | K040546 |
| Device Name: | IMAGE-ARENA AND RESEARCH-ARENA APPLICATIONS |
| Classification | System, Image Processing, Radiological |
| Applicant | TOMTEC IMAGING SYSTEMS, GMBH EDISONSTRASSE 6 Unterschleissheim, DE D-85716 |
| Contact | Ralf Janitz |
| Correspondent | Ralf Janitz TOMTEC IMAGING SYSTEMS, GMBH EDISONSTRASSE 6 Unterschleissheim, DE D-85716 |
| Product Code | LLZ |
| Subsequent Product Code | IYN |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-02 |
| Decision Date | 2004-04-27 |
| Summary: | summary |