The following data is part of a premarket notification filed by Viseon, Inc. with the FDA for Voyant System.
| Device ID | K181885 |
| 510k Number | K181885 |
| Device Name: | Voyant System |
| Classification | Arthroscope |
| Applicant | Viseon, Inc. 13900 Alton Parkway, Suite 125 Irvine, CA 92618 |
| Contact | Cora Sim |
| Correspondent | Cora Sim Viseon, Inc. 13900 Alton Parkway, Suite 125 Irvine, CA 92618 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-13 |
| Decision Date | 2018-10-02 |
| Summary: | summary |