The following data is part of a premarket notification filed by Xact Robotics, Ltd. with the FDA for Xact Robotic System, Ace Model.
| Device ID | K213759 |
| 510k Number | K213759 |
| Device Name: | XACT Robotic System, ACE Model |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | XACT Robotics, Ltd. 8 Hatochen Street, PO Box 3097 Caesarea, IL 3079861 |
| Contact | Dan Sigal |
| Correspondent | Jonathan S Kahan Hogan Lovells US LLP 555 Thirteenth Street NW Washington, DC 20004 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-30 |
| Decision Date | 2022-09-23 |