Device Classification Name |
Full Field Digital,System,X-Ray,Mammographic
More FDA Info for this Device |
510(K) Number |
K220073 |
Device Name |
Full Field Digital,System,X-Ray,Mammographic |
Applicant |
DRTECH Corporation
Suite No.1, 2 Floor / Suite No. 2, 3 Floor, 29
Dunchon-daero 541 beon-gil,
Jungwon-gu, Seongnam-si, 13216 KR
Other 510(k) Applications for this Company
|
Contact |
Suyeon Back
Other 510(k) Applications for this Contact |
Regulation Number |
000.0000
More FDA Info for this Regulation Number |
Classification Product Code |
MUE
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
01/10/2022 |
Decision Date |
01/26/2023 |
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 |
|