Device Classification Name |
solid state x-ray imager (flat panel/digital imager)
|
510(k) Number |
K221434 |
Device Name |
17HQ701G-B |
Applicant |
LG Electronics Inc. |
77, Sanho-daero |
Gumi-si,
KR
39381
|
|
Applicant Contact |
Jinhwan Jun |
Correspondent |
GMS Consulting |
4th Floor, Digital Cube, 34, Sangamsan-ro |
Seoul,
KR
03909
|
|
Correspondent Contact |
Woo Chai kyoung |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 05/17/2022 |
Decision Date | 07/13/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|