FDA 510(k) Applications Submitted by Samsung Medison Co., LTD
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K122583 |
08/24/2012 |
UGEO G60 DIAGNOSTIC ULTRASOUND SYSTEM |
SAMSUNG MEDISON CO., LTD |
| K220043 |
01/05/2022 |
HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System |
Samsung Medison Co., LTD |
| K202556 |
09/03/2020 |
HS30 Diagnostic Ultrasound System |
Samsung Medison Co., LTD |
| K191115 |
04/26/2019 |
RS85 Diagnostic Ultrasound System |
Samsung Medison Co., Ltd |
| K173204 |
10/02/2017 |
RS85 Diagnostic Ultrasound System |
Samsung Medison Co., Ltd |
| K192903 |
10/15/2019 |
RS85 Diagnostic Ultrasound System |
Samsung Medison Co., Ltd |
| K153408 |
11/25/2015 |
HM70A Diagnostic Ultrasound System |
SAMSUNG MEDISON CO., LTD |
| K151808 |
07/02/2015 |
3D/5D Viewer |
SAMSUNG MEDISON CO., LTD |
| K130803 |
03/22/2013 |
UGEO H70C DIAGNOSTIC ULTRASOUND SYSTEM |
SAMSUNG MEDISON CO., LTD |
| K132228 |
07/17/2013 |
UGEO PT60A DIAGNOSTIC ULTRASOUND SYSTEM |
SAMSUNG MEDISON CO., LTD |
| K162094 |
07/28/2016 |
RS80A Diagnostic Ultrasound System |
Samsung Medison Co., Ltd |
| K112339 |
08/15/2011 |
ACCUVIX A30 DIAGNOSTIC ULTRASOUND SYSTEM |
SAMSUNG MEDISON CO., LTD |
| K112646 |
09/12/2011 |
SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM |
SAMSUNG MEDISON CO., LTD |
| K132861 |
09/12/2013 |
UGEO H60 DIAGNOSTIC ULTRASOUND SYSTEM |
SAMSUNG MEDISON CO., LTD |
| K143264 |
11/13/2014 |
H60 V2.00 Diagnostic Ultrasound System |
SAMSUNG MEDISON CO., LTD |
| K113381 |
11/16/2011 |
MYSONO U6 DIAGNOSTIC ULTRASOUND SYSTEM |
SAMSUNG MEDISON CO., LTD |
| K141620 |
06/17/2014 |
RS80A DIAGNOSTIC ULTRASOUND SYSTEM |
SAMSUNG MEDISON CO., LTD |
| K142466 |
09/02/2014 |
UGEO PT60A Diagnostic Ultrasound System |
SAMSUNG MEDISON CO., LTD |
| K143089 |
10/28/2014 |
WS80A Diagnostic Ultrasound System |
SAMSUNG MEDISON CO., LTD |
| K133329 |
10/29/2013 |
UGEO WS80A DIAGNOSTIC ULTRASOUND SYSTEM |
SAMSUNG MEDISON CO., LTD |
| K133505 |
11/14/2013 |
SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM |
SAMSUNG MEDISON CO., LTD |
| K200339 |
02/11/2020 |
HS40 Diagnostic Ultrasound System |
Samsung Medison Co., LTD |
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