The following data is part of a premarket notification filed by Mivenion Gmbh with the FDA for Xiralite Flourescence Imaging System X4.
| Device ID | K130003 |
| 510k Number | K130003 |
| Device Name: | XIRALITE FLOURESCENCE IMAGING SYSTEM X4 |
| Classification | System, X-ray, Angiographic |
| Applicant | MIVENION GMBH ROBERT-KOCH-PLATZ 4 Berlin, DE 10115 |
| Contact | Malte Bahner |
| Correspondent | Malte Bahner MIVENION GMBH ROBERT-KOCH-PLATZ 4 Berlin, DE 10115 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2013-01-02 |
| Decision Date | 2014-01-31 |
| Summary: | summary |