Device Classification Name |
System, Image Processing, Radiological
More FDA Info for this Device |
510(K) Number |
K211114 |
Device Name |
System, Image Processing, Radiological |
Applicant |
HDX WILL CORP.
#105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong 4-ro,
Osong-eup, Heungdeok-gu
Cheongju-si 28161 KR
Other 510(k) Applications for this Company
|
Contact |
Kim In-Young
Other 510(k) Applications for this Contact |
Regulation Number |
892.2050
More FDA Info for this Regulation Number |
Classification Product Code |
LLZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
04/14/2021 |
Decision Date |
12/15/2021 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
RA - Radiology |
Review Advisory Committee |
RA - Radiology |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|