Device Classification Name |
Image-Intensified Fluoroscopic X-Ray System, Mobile
|
510(k) Number |
K170946 |
Device Name |
Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant |
Applicant |
Skanray Technologies Private Limited |
Plot 15-17 |
Hebbal Industrial Area |
Mysore,
IN
570016
|
|
Applicant Contact |
Mahadevan J. |
Correspondent |
Elexes Medical Consulting Pvt Ltd. |
#6494, Tralee Village Dr. |
Dr Dublin,
CA
94568
|
|
Correspondent Contact |
Parul Chansoria |
Regulation Number | 892.1650
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/30/2017 |
Decision Date | 11/24/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|