Question 1

What types of medical devices does Samsung Medison Co., Ltd. manufacture?

Accepted Answer

Samsung Medison Co., Ltd. specializes in ultrasound-related medical devices. Their portfolio includes general-purpose ultrasound imaging systems like the RS80A and HS60, which are used for a wide range of diagnostic imaging. They also produce specialized extracorporeal ultrasound imaging transducers, including hand-held models and rectal/vaginal probes such as the L3-12A and UGEO H70C. Additionally, the company offers ultrasound system workstations and radiological PACS (Picture Archiving and Communication System) software, like SonoSync and ECG/AHAINTHESYS, to support imaging workflows.

Question 2

Where is Samsung Medison Co., Ltd. based, and where are their devices developed and distributed?

Accepted Answer

Samsung Medison Co., Ltd. is based in South Korea. Their devices are developed and distributed from this location, ensuring a centralized approach to manufacturing, quality control, and global distribution of their ultrasound imaging systems and related technologies.

Question 3

Are Samsung Medison’s devices listed in any regulatory registries, and if so, which ones?

Accepted Answer

Yes, several of Samsung Medison’s devices are listed in regulatory registries. Specifically, their products appear in the FDA’s Unique Device Identifier (UDI) database, which serves as a standardized system for tracking medical devices in the United States. This listing helps ensure traceability and compliance with regulatory requirements.

Question 4

How are Samsung Medison’s medical devices classified under regulatory frameworks?

Accepted Answer

Samsung Medison’s devices are classified as Class II under regulatory frameworks. This classification typically applies to devices that pose moderate risk and require special controls to ensure their safety and effectiveness, such as many ultrasound systems and related imaging tools. The classification helps determine the regulatory pathway and oversight required for each product.

Device	Model / Reference	Registries	Class	Status
HS50 / HS60 Diagnostic Ultrasound System	USS-HS5PB3M/US	FDA UDI	Class II	Active
HS70A Diagnostic Ultrasound System	USS-HS7AF4N/US	FDA UDI	Class II	Active
Rs85	USS-RS85F4P/US	FDA UDI	Class II	Active
RS85 Diagnostic Ultrasound System	USS-RS85W40/US	FDA UDI	Class II	Active
Converting Box	USO-EP6CS10/US	FDA UDI	Class II	Active
Ev2-10a	USP-V02AN1B/WR	FDA UDI	Class II	Active
Cart 1-Probe	USO-CP6CN00/US	FDA UDI	Class II	Active
La4-18bd	USP-LF4IF4A/WR	FDA UDI	Class II	Active
Ecg Module Iec	USO-UW8EID0/WR	FDA UDI	Class II	Active
Hs40	USS-HS4NL40/WR	FDA UDI	Class II	Active
Hm70 Evo	USS-M7ENL30/US	FDA UDI	Class II	Active
HERA W9 Diagnostic Ultrasound System	USS-HRW9F4C/US	FDA UDI	Class II	Active
A35 Diagnostic Ultrasound System	USS-AV35L4V/WW	FDA UDI	Class II	Active
Transducer L5-13/50	USP-L05DD5B/WR	FDA UDI	Class II	Active
H60 V2.00 Diagnostic Ultrasound System	USS-H60NF4L/US	FDA UDI	Class II	Active
V5-9	USP-RV059F0AWR	FDA UDI	Class II	Active
Ecg Iec	USO-UH7EI00/WR	FDA UDI	Class II	Active
Hs40	USS-HS4PB3F/US	FDA UDI	Class II	Active
HM70 EVO Diagnostic Ultrasound System	USS-M7EPC1C/US	FDA UDI	Class II	Active
HERA W10 Diagnostic Ultrasound System	USS-HW1EF4E/US	FDA UDI	Class II	Active
Transducer LS6-15	USP-L06FD2A/WR	FDA UDI	Class II	Active
Transducer CA1-7AD	USP-CF17FSB/WR	FDA UDI	Class II	Active
Accessory Set	USO-YR3ANN0/WR	FDA UDI	Class II	Active
Ca2-9ad	USP-C029NSA/WR	FDA UDI	Class II	Active
Ea2-11ar	USP-EF2BF1A/WR	FDA UDI	Class II	Active
HS50 / HS60 Diagnostic Ultrasound System	USS-HS5NB4M/US	FDA UDI	Class II	Active
HS50 / HS60 Diagnostic Ultrasound System	USS-HS5NB3M/US	FDA UDI	Class II	Active
Hs40	USS-HS4PF40/WR	FDA UDI	Class II	Active
H60 Diagnostic Ultrasound System	USS-H60NF3L/US	FDA UDI	Class II	Active
Transducer V5-9	USP-V059F0A/WR	FDA UDI	Class II	Active
Ecg-Iec-H6	USO-UG6EI00/WR	FDA UDI	Class II	Active
HS50 / HS60 Diagnostic Ultrasound System	USS-HS5PB4M/US	FDA UDI	Class II	Active
HS40 Diagnostic Ultrasound System	USS-HS4NL30/US	FDA UDI	Class II	Active
Ecg	USO-US7EI00/WR	FDA UDI	Class II	Active
HS50 / HS60 Diagnostic Ultrasound System	USS-HS5NB4K/US	FDA UDI	Class II	Active
HS40 Diagnostic Ultrasound System	USS-HS4PF4B/US	FDA UDI	Class II	Active
HM70 EVO Diagnostic Ultrasound System	USS-M7ENCCC/US	FDA UDI	Class II	Active
Hs70a	USS-HS7AF4L/US	FDA UDI	Class II	Active
Transducer L7-16	USP-LZ7GDSA/WR	FDA UDI	Class II	Active
5d Ob Package	USO-UW85O0K/KR	FDA UDI	Class II	Active
Sonoace R3 Cart	USO-CR3CN01/CN	FDA UDI	Class II	Active
HS50 Diagnostic Ultrasound System	USS-HS5FB3N/US	FDA UDI	Class II	Active
HERA W9 Diagnostic Ultrasound System	USS-HRW9F30/US	FDA UDI	Class II	Active
Sonoace R3 Cart	USO-CR3CN01/BR	FDA UDI	Class II	Active
Clear Track Package	USO-UR8CIL0/WR	FDA UDI	Class II	Active
HERA W10 Diagnostic Ultrasound System	USS-HRW1Q4C/US	FDA UDI	Class II	Active
RS85 Diagnostic Ultrasound System	USS-RS85F4F/US	FDA UDI	Class II	Active
Accessory Set	USO-YV6ANN0/WR	FDA UDI	Class II	Active
WS80A Diagnostic Ultrasound System	USS-WS8AL44/WW	FDA UDI	Class II	Active
HS50 / HS60 Diagnostic Ultrasound System	USS-HS5PF4K/US	FDA UDI	Class II	Active

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