The following data is part of a premarket notification filed by Xact Robotics Ltd. with the FDA for Xact Ace Robotic System.
| Device ID | K221116 |
| 510k Number | K221116 |
| Device Name: | XACT ACE Robotic System |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | XACT Robotics Ltd. 8 Hatochen Street, PO Box 3097 Caesarea, IL 3079861 |
| Contact | Chen Levin |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-15 |
| Decision Date | 2022-05-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290017702018 | K221116 | 000 |