The following data is part of a premarket notification filed by Activ Surgical, Inc. with the FDA for Activsight Intraoperative Imaging System.
| Device ID | K203550 |
| 510k Number | K203550 |
| Device Name: | ActivSight Intraoperative Imaging System |
| Classification | Confocal Optical Imaging |
| Applicant | Activ Surgical, Inc. 840 Summer Street Boston, MA 02127 |
| Contact | Matthew King |
| Correspondent | Matthew King Activ Surgical, Inc. 840 Summer Street Boston, MA 02127 |
| Product Code | OWN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-04 |
| Decision Date | 2021-04-08 |