SIT
- Product code
- SIT
- Device name
- Arthroscopic Or Orthopedic Endoscopic Intraoperative Augmented Reality Video See-Through Display System
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.1150
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
FDA classification definition
This device consists of augmented reality software on a head-mounted display that displays arthroscopic or endoscopic video and medical imaging during orthopedic surgery. The device is intended to intraoperatively augment visualization with contextually relevant information and data, including that received from other devices.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| DEN250040 | 2026-07-17 | Stryker Endoscopy | SportSuite Vision Software | — |
Official FDA classification page: SIT
Classification and pathway per current FDA publications. Data from openFDA (CC0).