The following data is part of a premarket notification filed by Tomtec Imaging Systems, Gmbh with the FDA for 4d Lv-analysis 3.0.
| Device ID | K110746 |
| 510k Number | K110746 |
| Device Name: | 4D LV-ANALYSIS 3.0 |
| Classification | Computer, Diagnostic, Programmable |
| 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 | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-17 |
| Decision Date | 2011-05-24 |
| Summary: | summary |