Device Classification Name |
X-Ray, Tomography, Computed, Dental
More FDA Info for this Device |
510(K) Number |
K220392 |
Device Name |
X-Ray, Tomography, Computed, Dental |
Applicant |
GENORAY Co., Ltd.
#512, 560, Dunchon-daero, Jungwon-gu
Seongnam-si 13230 KR
Other 510(k) Applications for this Company
|
Contact |
Jiyeon Lee
Other 510(k) Applications for this Contact |
Regulation Number |
892.1750
More FDA Info for this Regulation Number |
Classification Product Code |
OAS
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
02/11/2022 |
Decision Date |
05/19/2022 |
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 |
|