Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K251639
xvision Spine system · Augmedics, Ltd. · decided 2025-10-03 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| C-arm adaptor enclosure | AMCH07702 | AUGMEDICS LTD | SBF | 07290113781139 |
| X2 Headset Battery LARGE | ABAT00003 | AUGMEDICS LTD | SBF | 07290113781719 |
| X2 Accessories Kit | X2001002 | AUGMEDICS LTD | SBF | 07290113781702 |
| X2 Headset | X2001001 | AUGMEDICS LTD | SBF | 07290113781696 |
| X2 Headset Battery SMALL | ABAT00004 | AUGMEDICS LTD | SBF | 07290113781726 |