The following data is part of a premarket notification filed by Viseon, Inc. with the FDA for Voyant System.
| Device ID | K191579 |
| 510k Number | K191579 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-14 |
| Decision Date | 2019-07-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850007069254 | K191579 | 000 |
| 00850007069117 | K191579 | 000 |
| 00850007069100 | K191579 | 000 |
| 00850007069094 | K191579 | 000 |
| 00850007069087 | K191579 | 000 |
| 00850007069070 | K191579 | 000 |
| 00850007069063 | K191579 | 000 |
| 00850007069056 | K191579 | 000 |
| 00850007069049 | K191579 | 000 |
| 00850007069032 | K191579 | 000 |
| 00850007069025 | K191579 | 000 |
| 00850007069018 | K191579 | 000 |
| 00850007069124 | K191579 | 000 |
| 00850007069131 | K191579 | 000 |
| 00850007069247 | K191579 | 000 |
| 00850007069230 | K191579 | 000 |
| 00850007069223 | K191579 | 000 |
| 00850007069216 | K191579 | 000 |
| 00850007069209 | K191579 | 000 |
| 00850007069193 | K191579 | 000 |
| 00850007069186 | K191579 | 000 |
| 00850007069179 | K191579 | 000 |
| 00850007069162 | K191579 | 000 |
| 00850007069155 | K191579 | 000 |
| 00850007069148 | K191579 | 000 |
| 00850007069001 | K191579 | 000 |