FDA 510(k) Applications Submitted by Sang Bong Lee
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K180473 |
02/22/2018 |
ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR |
ECOTRON Co., Ltd |
| K221233 |
04/29/2022 |
DT-703 |
ECOTRON Co., Ltd |
| K160279 |
02/02/2016 |
ANYVIEW-500R Fluoroscopic Mobile X-Ray System |
ECOTRON CO.,LTD |
| K151038 |
04/20/2015 |
EPX-Series Mobile X-ray System |
ECOTRON CO.,LTD |
| K222466 |
08/16/2022 |
AirTom |
Bilab |
| K160065 |
01/13/2016 |
GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System |
GEMSS MEDICAL SYSTEMS CO., LTD |
| K231181 |
04/26/2023 |
bright CT |
Dentium Co., Ltd (ICT Branch) |
| K163140 |
11/09/2016 |
SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System |
GEMSS MEDICAL SYSTEMS CO., LTD |
| K242931 |
09/25/2024 |
HFT750U |
MEKICS Co., Ltd. |
| K243644 |
11/26/2024 |
Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302) |
CERAGEM Co, Ltd. |
| K200270 |
02/04/2020 |
rainbow MCT |
Dentium Co., Ltd (ICT Branch) |
| K200271 |
02/04/2020 |
rainbow CT |
Dentium Co., Ltd (ICT Branch) |
| K201247 |
05/11/2020 |
Intraoral Sensor |
Dentium Co., Ltd (ICT Branch) |
| K193341 |
12/03/2019 |
iCTmotor (WL-1) |
Dentium Co., Ltd |
| K233805 |
11/29/2023 |
K5 |
OSSTEM Implant Co., Ltd. Chair Business |
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