The following data is part of a premarket notification filed by Eemagine Medical Imaging Solutions Gmbh with the FDA for Visor2 System.
| Device ID | K210109 |
| 510k Number | K210109 |
| Device Name: | Visor2 System |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | Eemagine Medical Imaging Solutions GmbH Gubenerstr. 47, Fabrik D-10243 Berlin, DE |
| Contact | Maarten Van De Velde |
| Correspondent | Gary J Syring Quality & Regulatory Associates, LLC 800 Levanger Lane Stoughton, WI 53589 |
| Product Code | HAW |
| Subsequent Product Code | GWF |
| Subsequent Product Code | IKN |
| Subsequent Product Code | OBP |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-19 |
| Decision Date | 2022-04-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B195ES600US0 | K210109 | 000 |
| B195NT123 | K210109 | 000 |
| B195NT120 | K210109 | 000 |
| B195NT118 | K210109 | 000 |
| B195NT117 | K210109 | 000 |
| B195NT112 | K210109 | 000 |
| B195NT109 | K210109 | 000 |
| B195NT106 | K210109 | 000 |
| B195NT1041 | K210109 | 000 |
| B195NT124 | K210109 | 000 |
| B195NT125 | K210109 | 000 |
| B195NT126 | K210109 | 000 |
| B195NT105 | K210109 | 000 |
| B195NT159 | K210109 | 000 |
| B195NT158 | K210109 | 000 |
| B195NT157 | K210109 | 000 |
| B195NT148 | K210109 | 000 |
| B195NT143 | K210109 | 000 |
| B195NT134 | K210109 | 000 |
| B195NT133 | K210109 | 000 |
| B195NT1040 | K210109 | 000 |