The following data is part of a premarket notification filed by 7d Surgical Inc. with the FDA for Envision 3d: Image Guidance System.
| Device ID | K162375 |
| 510k Number | K162375 |
| Device Name: | Envision 3D: Image Guidance System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | 7D SURGICAL INC. 60 SCARSDALE ROAD, UNIT 118 Toronto, CA M3b 2r7 |
| Contact | Daniel Ziskind |
| Correspondent | Daniel Ziskind 7D SURGICAL INC. 60 SCARSDALE ROAD, UNIT 118 Toronto, CA M3b 2r7 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-24 |
| Decision Date | 2016-12-29 |
| Summary: | summary |