Device Classification Name |
accelerator, linear, medical
|
510(k) Number |
K162002 |
Device Name |
Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay |
Applicant |
ZDi, Solutions, LLC |
800 S Gay St, STE 714 |
Knoxville,
TN
37909
|
|
Applicant Contact |
Zachary A. Dutton |
Correspondent |
ZDi, Solutions, LLC |
800 S Gay St, STE 714 |
Knoxville,
TN
37909
|
|
Correspondent Contact |
Zachary A. Dutton |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 07/20/2016 |
Decision Date | 11/01/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|