Device Classification Name |
System, X-Ray, Tomography, Computed
|
510(k) Number |
K213759 |
Device Name |
XACT Robotic System, ACE Model |
Applicant |
XACT Robotics, Ltd. |
8 Hatochen Street, PO Box 3097 |
Caesarea,
IL
3079861
|
|
Applicant Contact |
Dan Sigal |
Correspondent |
Hogan Lovells US LLP |
555 Thirteenth Street NW |
Washington,
DC
20004
|
|
Correspondent Contact |
Jonathan S Kahan |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 11/30/2021 |
Decision Date | 09/23/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|