K210109 is an FDA 510(k) clearance for the visor2 system. This device is classified as a Neurological Stereotaxic Instrument (Class II - Special Controls, product code HAW).
Submitted by Eemagine Medical Imaging Solutions GmbH (Berlin, DE). The FDA issued a Cleared decision on April 8, 2022, 444 days after receiving the submission on January 19, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4560.
| 510(k) Number | K210109 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 19, 2021 |
| Decision Date | April 08, 2022 |
| Days to Decision | 444 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HAW - Neurological Stereotaxic Instrument |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4560 |