Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K211480 |
Device Name |
NubeX |
Applicant |
TechHeim Co., Ltd |
Floor 3.4, 21, Banpo-daero 24-gil |
Seoul,
KR
06648
|
|
Applicant Contact |
Weon Yong Lee |
Correspondent |
KMC, Inc. |
Room no. 1709, 123, Digital-ro 26-gil, Guro-gu |
Seoul,
KR
08390
|
|
Correspondent Contact |
JeongKeun Kim |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 05/12/2021 |
Decision Date | 07/08/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|