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	USS-HS5NL30/WR	FDA UDI	Class II	Active
PT60A Diagnostic Ultrasound System	USS-PT6AE3A/US	FDA UDI	Class II	Active
Transducer L3-12A	USP-L03CF5B/WR	FDA UDI	Class II	Active
Transducer L3-8	USP-L038E0A/WR	FDA UDI	Class II	Active
Transducer L3-12A	USP-L03CF0A/WR	FDA UDI	Class II	Active
HM70 EVO Diagnostic Ultrasound System	USS-M7ENF1C/US	FDA UDI	Class II	Active
HM70 EVO Diagnostic Ultrasound System	USS-M7ENLCC/US	FDA UDI	Class II	Active
HS30 Diagnostic Ultrasound System	USS-HS3NL20/US	FDA UDI	Class II	Active
RS80A Diagnostic Ultrasound System	USS-RS8CF4K/US	FDA UDI	Class II	Active
HERA W9, HERA W10 Diagnostic Ultrasound System	USS-HRW9F3D/US	FDA UDI	Class II	Active
HS40 Diagnostic Ultrasound System	USS-HS4PB3D/US	FDA UDI	Class II	Active
HS70A Diagnostic Ultrasound System	USS-HS7AL30/US	FDA UDI	Class II	Active
Mitsubishi P95DE	USO-P0NBMI0/WR	FDA UDI	Class II	Active
Ev2-10a	USP-V02AN1A/WR	FDA UDI	Class II	Active
C2-8	USP-C028N6A/WR	FDA UDI	Class II	Active
ECG Module(AHA)	K150478	FDA UDI	Class II	Active
HM70 EVO Diagnostic Ultrasound System	USS-M7ENNCC/US	FDA UDI	Class II	Active
Accessory Set	USO-YH6ANN0/WR	FDA UDI	Class II	Active
Ev4-9/10ed	USP-GZ49BDB/WR	FDA UDI	Class II	Active
H60 Diagnostic Ultrasound System	USS-H60NF3L/WW	FDA UDI	Class II	Active
Accessory Set	USO-YV3ANN0/WR	FDA UDI	Class II	Active
HS70A Diagnostic Ultrasound System	USS-HS7AL4N/US	FDA UDI	Class II	Active
Transducer SP3-8	USP-P038ESA/WR	FDA UDI	Class II	Active
HS50 / HS60 Diagnostic Ultrasound System	USS-HS6PB4K/US	FDA UDI	Class II	Active
Transducer LA3-16A	USP-L03GD4B/WR	FDA UDI	Class II	Active
Hm70 Evo	USS-M7EPF30/US	FDA UDI	Class II	Active
Cv1-8a	USP-V018FSC/WR	FDA UDI	Class II	Active
Transducer ER4-9	USP-U049F1A/WR	FDA UDI	Class II	Active
Transducer PN2-4	USP-PN24E0A/WR	FDA UDI	Class II	Active
Hs40	USS-HS4NG4F/US	FDA UDI	Class II	Active
HS40 Diagnostic Ultrasound System	USS-HS4NL3B/US	FDA UDI	Class II	Active
HM70A Diagnostic Ultrasound System	USS-HM7AF1L/US	FDA UDI	Class II	Active
Hs40	USS-HS4NG3F/US	FDA UDI	Class II	Active
Transducer CV1-8AD	USP-V018NSA/WR	FDA UDI	Class II	Active
La3-16ad	LA3-16AD	FDA UDI	Class II	Active
Transducer CF4-9	USP-CF49D2A/WR	FDA UDI	Class II	Active
Hm70 Evo	USS-M7ENF30/US	FDA UDI	Class II	Active
Transducer C2-8	USP-C028E0A/WR	FDA UDI	Class II	Active
SONOACE R7 Diagnostic Ultrasound System	USS-SAR7E3U/WW	FDA UDI	Class II	Active
Hs40	USS-HS4NL40/WW	FDA UDI	Class II	Active
Mitsubish CP30DW	USO-P0NCMA0/WR	FDA UDI	Class II	Active
Transducer VE4-8	USP-VE48F5A/WR	FDA UDI	Class II	Active
Transducer EVN4-9	USP-G049G1A/WR	FDA UDI	Class II	Active
HS30 Diagnostic Ultrasound System	USS-HS3NL2B/US	FDA UDI	Class II	Active
Accessory Set	USO-YR5ANN0/WR	FDA UDI	Class II	Active
Hs40	USS-HS4NL4E/US	FDA UDI	Class II	Active
Transducer P4-12	USP-P04CG0A/WR	FDA UDI	Class II	Active
Transducer CN2-8	USP-CN28E0B/WR	FDA UDI	Class II	Active
HERA W9 Diagnostic Ultrasound System	USS-HRW9F3E/US	FDA UDI	Class II	Active
Hs50	USS-HS5PF30/WR	FDA UDI	Class II	Active

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