FDA 510(k) Applications Submitted by JI YEA LEE
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K140864 |
04/03/2014 |
VELOXTM INTERBODY FUSION SYSTEM |
U&I CORP. |
| K202556 |
09/03/2020 |
HS30 Diagnostic Ultrasound System |
Samsung Medison Co., LTD |
| K173513 |
11/13/2017 |
WS80A Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
| K180409 |
02/14/2018 |
HS40 Diagnostic Ultrasound System |
Samsung Medison Co, Ltd. |
| K190444 |
02/25/2019 |
HERA I10 Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
| K200699 |
03/17/2020 |
HS70A Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
| K180883 |
04/04/2018 |
5D Viewer |
Samsung Medison Co., Ltd. |
| K171048 |
04/07/2017 |
RS80A Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
| K191115 |
04/26/2019 |
RS85 Diagnostic Ultrasound System |
Samsung Medison Co., Ltd |
| K181336 |
05/21/2018 |
HS50 / HS60 Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
| K192030 |
07/30/2019 |
RS80 EVO Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
| K162189 |
08/04/2016 |
ANAXÖ 5.5 Spinal System |
U&I Corporation |
| K192319 |
08/26/2019 |
HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
| K182595 |
09/20/2018 |
HERA W10 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 |
| K182932 |
10/22/2018 |
RS85 Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
| K173713 |
12/04/2017 |
HS70A Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
| K120702 |
03/08/2012 |
E.G. SCAN II ESPHAGOSCOPE SYSTEM |
INTROMEDIC CO., LTD |
| K202929 |
09/29/2020 |
Nexpowder |
Nextbiomedical Co., Ltd. |
| K150344 |
02/11/2015 |
Dentis Dental Implant System |
DENTIS CO., LTD. |
| K222707 |
09/07/2022 |
IH Implant System |
Sewon Medix Inc. |
| K170438 |
02/13/2017 |
MiroCam Capsule Endoscope System |
IntroMedic Co., Ltd. |
| K180732 |
03/20/2018 |
MiroCam Capsule Endoscope System |
IntroMedic Co., Ltd. |
| K140751 |
03/25/2014 |
MIROCAM CAPSULE ENDOSCOPE SYSTEM |
INTROMEDIC CO., LTD |
| K111030 |
04/13/2011 |
E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM |
INTROMEDIC CO., LTD |
| K143663 |
12/23/2014 |
MiroCam Capsule Endoscope System |
INTROMEDIC CO., LTD |
| K134005 |
12/27/2013 |
MIROCAM CAPSULE ENDOSCOPE SYSTEM |
INTROMEDIC CO., LTD |
| K160363 |
02/09/2016 |
OPTIMUS CMF SYSTEM |
OSTEONIC Co., Ltd. |
| K220926 |
03/31/2022 |
Spectra Wearable |
Uzinmedicare Co., Ltd. |
| K191109 |
04/26/2019 |
Spectra Q |
Uzinmedicare Co. |
| K220392 |
02/11/2022 |
PAPAYA 3D & PAPAYA 3D Plus |
GENORAY Co., Ltd. |
| K220423 |
02/14/2022 |
PAPAYA & PAPAYA Plus |
GENORAY Co., Ltd. |
| K230787 |
03/22/2023 |
Oscar 15 & Oscar 15i |
Genoray Co., Ltd. |
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