Device Classification Name |
Solid State X-Ray Imager (Flat Panel/Digital Imager)
|
510(k) Number |
K172435 |
Device Name |
Galaxy R Digital Radiography Upgrade |
Applicant |
MEDIEN INTERNATIONAL CO LTD |
Medien Office Tower, 50, Heungan-daero 427 Beon-gil Dongan-g |
Anyang-Si,
KR
435-040
|
|
Applicant Contact |
Jae Hyun Lee |
Correspondent |
Kamm & Associates |
8870 Ravello Ct |
Naples,
FL
34114
|
|
Correspondent Contact |
Daniel Kamm |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 08/11/2017 |
Decision Date | 10/13/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|