Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8041160

FEI Number

3010289997

Entity Name

SAMSUNG MEDISON CO., LTD.

City/State/Country

HONGCHEON-GUN Gangwon, KR

Establishment Address

3366, Hanseo-ro, Nam-myeon, HONGCHEON-GUN Gangwon 25108, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SAMSUNG MEDISON CO., LTD. (Owner Number: 8041160)

Owner / Operator Contact Address

3366, Hanseo-ro, Nam-myeon,, Hongcheon-gun, KR-42 25108, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K170493

PMA Number

N/A

All Registered Proprietary Names

RS85 RS80 EVO SonoSync H6 V6 H8 V8 H7 V7 RS80A HS70A HERA Z20 HERA Z30 R20 R30 Z20 HERA Z20s HERA Z20e cV4 Diagnostic Ultrasound System V5 Diagnostic Ultrasound System V8 Diagnostic Ultrasound System cV7 Diagnostic Ultrasound System V6 Diagnostic Ultrasound System cV5 Diagnostic Ultrasound System cV8 Diagnostic Ultrasound System V7 Diagnostic Ultrasound System cV6 Diagnostic Ultrasound System V4 Diagnostic Ultrasound System WS80A HS30 System HS30 Ultrasound System UGEO PT60A PT60A HM70 EVO HS50 / HS60 Diagnostic Ultrasound System HERA W10 HERA W9 V7 V8 HS70A Diagnostic Ultrasound System HM70 EVO V6 Diagnostic Ultrasound System V8 Diagnostic Ultrasound System V7 Diagnostic Ultrasound System HS40 Diagnostic Ultrasound System HS30 Diagnostic Ultrasound System RS85 Diagnostic Ultrasound System RS85 Ultrasound System V8 EKO 7 V7 Diagnostic Ultrasound System V6 Diagnostic Ultrasound System cV7 Diagnostic Ultrasound System cV6 Diagnostic Ultrasound System V8 Diagnostic Ultrasound System cV8 Diagnostic Ultrasound System WS80A UGEO WS80A UGEO HM70A HM70A RS80A UGEO PT60A RS85 Diagnostic Ultrasound System HERA W10 Diagnostic Ultrasound System HERA W9 Diagnostic Ultrasound System HS70A hera I10 Diagnostic Ultrasound System HERA I10 Diagnostic Ultrasound System I10 Diagnostic Ultrasound System RS80 EVO System RS80 evo Diagnostic Ultrasound System RS80 evo System RS85 Diagnostic Ultrasound System RS85 Prestige RS85 Prestige Diagnostic Ultrasound System RS80A RS80A WS80A V8 V7 RS85 RS80 EVO RS85 Prestige HM70 EVO A35 ACCUVIX A30 V8 HS40 Diagnostic Ultrasound System HS60 HS50 HS40 RS85 HERA W10 Diagnostic Ultrasound System HS40 HS40 5D Viewer SONOACE R5 ACCUVIX XG 5D Viewer RS80A H60 iChair MySono U6 HS40 Ultrasound System HS40 System HS40 diagnostic ultrasound system HS40 Diagnostic Ultrasound System UGEO HM70A HM70A R30 Diagnostic Ultrasound System R26 Elite Diagnostic Ultrasound System HERA W20 Plus Diagnostic Ultrasound System R20 Plus Diagnostic Ultrasound System R30 Plus Diagnostic Ultrasound System XR20 Diagnostic Ultrasound System HERA W12 Plus Diagnostic Ultrasound System R26 Exp Diagnostic Ultrasound System HERA XW12 Diagnostic Ultrasound System R26 Diagnostic Ultrasound System HERA Z20 Diagnostic Ultrasound System HERA W20 Diagnostic Ultrasound System XR26 Diagnostic Ultrasound System HERA XW30 Diagnostic Ultrasound System R30 Elite Diagnostic Ultrasound System HERA XZ20 Diagnostic Ultrasound System R20 Diagnostic Ultrasound System R30 Exp Diagnostic Ultrasound System HERA Z20s Diagnostic Ultrasound System HERA Z20e Diagnostic Ultrasound System HERA W30 Diagnostic Ultrasound System HERA W30 Elite Diagnostic Ultrasound System R20 Exp Diagnostic Ultrasound System HERA W12 Elite Diagnostic Ultrasound System HERA XZ30 Diagnostic Ultrasound System HERA W30 Plus Diagnostic Ultrasound System HERA W20 Elite Diagnostic Ultrasound System R20 Elite Diagnostic Ultrasound System HERA XW20 Diagnostic Ultrasound System R26 Plus Diagnostic Ultrasound System HERA W12 Diagnostic Ultrasound System XR30 Diagnostic Ultrasound System HERA Z30 Diagnostic Ultrasound System HERA W10 HERA W9 HS50 Diagnostics Ultrasound System HS60 Diagnostics Ultrasound System HS50/HS60 Diagnostics Ultrasound System SONOACE R7 3D/5D Viewer HS60 HS50

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2022-06-19
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2022-06-19
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2022-06-19
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2024-08-26
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-08-26
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-08-26
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-10-10
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-10-10
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-10-10
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-08-29
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-08-29
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2017-08-29
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2015-11-03
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2015-11-03
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2015-11-03
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2024-10-13
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-10-13
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-10-13
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-10-13
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-07-31
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-07-31
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2025-07-31
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2025-07-31
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-07-31
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-02-02
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-02-02
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-02-02
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-11-01
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-11-01
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-11-01
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2014-10-30
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2014-10-30
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2014-10-30
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-07-11
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-07-11
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-07-11
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-12-04
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2018-12-04
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-12-04
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-04-23
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-04-23
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-04-23
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2022-06-30
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2022-06-30
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2022-06-30
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-03-08
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2018-03-08
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-03-08
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2022-05-08
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2022-05-08
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2022-05-08
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-06-23
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-06-23
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-06-23
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2018-05-14
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-05-14
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-05-14
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2019-01-08
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2019-01-08
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2019-01-08
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2019-06-12
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2019-06-12
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2019-06-12
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-09-09
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-09-09
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-09-09
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2010-08-02
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2010-08-02
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2010-08-02
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2025-02-14
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-02-14
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-02-14
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-02-14
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2025-02-14
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-08-09
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-08-09
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2017-08-09
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2013-12-05
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2013-12-05
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2013-12-05
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2013-04-16
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2013-04-16
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2013-04-16
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2015-08-13
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2015-08-13
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2015-08-13
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2013-08-26
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2013-08-26
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2013-08-26
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-02-05
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-02-05
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2018-02-05
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2024-11-28
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-11-28
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-11-28
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-11-28
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-02-23
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-02-23
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2017-02-23
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2019-05-22
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2019-05-22
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2019-05-22
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2019-09-19
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2019-09-19
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2019-09-19
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-01-06
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-01-06
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-01-06
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2014-07-03
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2014-07-03
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2014-07-03
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-08-28
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-08-28
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-08-28
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2014-11-30
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2014-11-30
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2014-11-30
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-02-14
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-02-14
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-02-14
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-06-24
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-06-24
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-06-24
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-12-25
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-12-25
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-12-25
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2015-03-29
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2015-03-29
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2015-03-29
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-09-08
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-09-08
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-09-08
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2019-06-12
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2019-06-12
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2019-06-12
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-04-13
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-04-13
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-04-13
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-08-16
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-08-16
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2017-08-16
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-06-14
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-06-14
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-06-14
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2018-12-18
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-12-18
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-12-18
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-05-13
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-05-13
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-05-13
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2022-08-23
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2022-08-23
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2022-08-23
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2016-08-18
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2011-01-18
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2011-01-18
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2011-01-18
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2011-03-06
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2011-03-06
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2011-03-06
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-05-15
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-10-14
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-10-14
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-10-14
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2014-12-11
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2014-12-11
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2014-12-11
GBB	Chair, Surgical, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2021-01-11
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2012-01-17
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2012-01-17
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2012-01-17
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-04-07
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-04-07
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-04-07
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2015-12-22
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2015-12-22
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2015-12-22
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2026-01-19
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2026-01-19
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2026-01-19
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2026-01-19
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2026-01-19
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2022-04-06
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2022-04-06
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2022-04-06
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2019-12-12
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2019-12-12
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2019-12-12
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2011-10-19
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2011-10-19
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2011-10-19
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2015-08-03
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-03-28
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2017-03-28
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-03-28

Official Correspondent

Lisa Jang

US Agent Details

Ninad Gujar Business: Samsung HME America, Inc. Email: ngujar@samsunghme.com Phone: (978) 5648632

Related Public Records

Same Entity

SAMSUNG MEDISON CO., LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3009758186	SAMSUNG MEDISON CO., LTD.	Gumi-si Gyeongbuk, KR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K951723	GE Medical Systems	GE B510 TRANSDUCER	1995-11-14
K903562	Diasonics, Inc.	CW DOPPLER 2.25 MHZ PROBE	1992-03-02
K945318	Tetra Corp.	TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA	1995-05-05
K231666	FUJIFILM Healthcare Americas Corporation	Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)	2023-12-13
K882805	Coopervision-Cilco	CILCO VILLASENOR PACHYMETER	1988-08-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2022	DJO, LLC	2	GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 2082/ INTELECT RPW 100 V, 2760/ INTELECT LEGEND XT COMBOUS STD, 2791/ INTELECT LEGEND XT COMBO US STD W/CART, 2782-10/ INTELECT TRANSPORT US STD, 2782-2/ INTELECT TRANSPORT US STD, 2843/ INTELECT VET 4CH COMBO PKG, 2845K/ KIT INTELECT VET 4CH COMBO PKG, 2863/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 5CM, 2863-10/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 10CM APPL, 2863-2/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 2CM APPL, 2864/ SENIOR SOLUTIONS 4CH COMBO PKG US STD, 2761/ VECTRA GENISYS 2CH COMBO PKG US STD 5CM APPL, 2792/ VECTRA GENISYS 2CH COMBO US STD W/CART, 2761-10/ VECTRA GENISYS 2CH COMBO PKG US STD 10CM APPL, 2761-2/ VECTRA GENISYS 2CH COMBO PKG US STD 2CM APPL, 2762CC/ INT ADV 2CH COLOR COMBO INT'L 5CM APPL, 2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 10CM APPL, 2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 2CM APPL, 2788/ LEGEND XT 4CH COMBO PKG US STD 5CM APPL, 2795/ INTELECT XT 4CH COMBO US STD 5CM APPL W/CART, 2788-10/ LEGEND XT 4CH COMBO PKG US STD 10CM APPL, 2795-10/ INTELECT XT4CH COMBO US STD 10CM APPL, 2788-2/ LEGEND XT 4CH COMBO PKG US STD 2CM APPL, 2795-2/ INTELECT XT 4CH COMBO US STD 2CM APPL, 2789/ VECTRA GENISYS 4CH COMBO PKG US 5CM APPL, 2796/ VECTRA GENISYS 4CH COMBO US STD W/CART, 2796K/ KIT VECTRA GENISYS 4CH COMBO P, 2789-10/ VECTRA GENISYS 4CH COMBO PKG US STD 10CM APPL, 2796-10/ VECTRA GENISYS 4CH COMBO US US STD 10CM APPL, 2789-2/ VECTRA GENISYS 4CH COMBO PKG US STD 2CM APPL, 2796-2/ VECTRA GENISYS 4CH COMBO US STD 2CM APPL, 2738/ INTELECT TRANSPORT COMBO PKG US STD, 8250KP/ KIT TRITON DTS PROMO, 6001/ INTELECT NEO, 2738-10/ INTELECT TRANSPORT COMBO PKG US STD, 2738-2/ INTELECT TRANSPORT COMBO PKG US STD, 2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD, 2776/ INTELECT MOBILE INT'L STD 5CM APPL, 27800/ ULTRASOUND ON CART, 2776-BR/ INTELECT MOBILE INTL STD 5CM APPL BRAZIL, 2776-10/ INT MOBIL INT'L STD 10CM APPL, 2776-2/ INT MOBILE INT'L STD 2CM APPL, 2778/ INTELECT MOBILE COMBO INT'L STD 5CM APPL, 2778-10/ INTELECT MOBILE COMBO INT'L STD 10CM APPL, 2778-2/ INTELECT MOBILE COMBO INT'L STD 2CM APPL, 2752CC/ INT ADV 2CH COLOR COMBO INT'L STD, 2756/ INTELECT VET 2CH COMBO PKG INT'L STD, 2844K/ KIT INTELECT VET 2CH COMBO PKG, 2782/ INTELECT TRANSPORT US STD, 2895K/ KIT CART ADAPT BL W/CT/SPEC US, 2872/ VECTRA GEN 2C COMBO W/O EMG PK US STD, 2876/ VECTR GEN 2C COMBO W/O EMG US STD W/CART, 2874/ VECTRA GEN 4C COMBO W/O EMG PK US STD, 2878/ VECTR GEN 4C COMBO W/O EM US STD W/CART, 7550/ INT LEGEND COMBO 4C US STD, INT001/ INTELECT LEGEND ULTRASOUND US STD, INTC B/ INT CB PKGD US STD, 39-0701/ DIRECT SUPPLY PANACEA VECTRA 2-CHNL ULTRASOUND/ESTIM COMBO, 39-0702/ DIRECT SUPPLY PANACEA VECTRA 4-CHNL ULTRASOUND/ESTIM COMBO, 13-4248/ GEL CONDUCTOR 24-8.5OZ BOTTLES, 15-1200/ INTELECT MOBILE 2 ULTRASOUND INTL SET EU PLUG, 15-1201/ INTELECT MOBILE 2 ULTRASOUND INTL SET ALL PLUGS, 15-1204/ INTELECT MOBILE 2 COMBO INTL SET EU PLUG, 15-1205/ INTELECT MOBILE 2 COMBO INTL SET ALL PLUGS, 2173KIT/ INTELECT RPW 2 120V INTERNATIONAL KIT US PLUG, 2174KIT/ INTELECT RPW 2 230V KIT EU PLUG, 2175KIT/ INTELECT RPW 2 100V KIT JPN PLUG, 2176KIT/ INTELECT RPW 2 120V USA KIT, 12-2756-1/ INTELECT VET 2CH COMBO PKG INTL STD, 2756K/ KIT INTELECT VET 2CH COMBO PKGUS STD, 70002/ NEO MODULE ULTRASOUND
Z-0010-2022	DJO, LLC	2	Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:
Z-0029-2022	Aesthetics Systems Usa Inc	2	Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Z-0038-2026	ImaCor Inc.	2	ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
Z-0003-2011	Verathon, Inc.	2	BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8041160. Last updated year: 2026. Please use registration number 8041160 when referencing this establishment in official correspondence.