The following data is part of a premarket notification filed by Somatex Medical Technologies Gmbh with the FDA for Tumark Vision.
| Device ID | K180443 |
| 510k Number | K180443 |
| Device Name: | Tumark Vision |
| Classification | Marker, Radiographic, Implantable |
| Applicant | SOMATEX Medical Technologies GmbH Rheinstr. 7d Teltow, DE 14513 |
| Contact | Burkhard Jakob |
| Correspondent | Burkhard Jakob SOMATEX Medical Technologies GmbH Rheinstr. 7d Teltow, DE 14513 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-20 |
| Decision Date | 2018-03-22 |
| Summary: | summary |