Device Classification Name |
Full Field Digital,System,X-Ray,Mammographic
More FDA Info for this Device |
510(K) Number |
K162670 |
Device Name |
Full Field Digital,System,X-Ray,Mammographic |
Applicant |
DRTECH CORPORATION
SUITE NO.2, 3 FLOOR, 29, DUNCHON-DAERO541BEON-GIL,
JUNGWON-GU
SEONGNAM-SI 13230 KR
Other 510(k) Applications for this Company
|
Contact |
CHOUL-WOO SHIN
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 |
09/26/2016 |
Decision Date |
02/23/2017 |
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 |
|