# Samsung Medison Co., Ltd. (manufacturer, HONGCHEON-GUN Gangwon, KR): 13 new FDA device listings, incl. system, imaging, pulsed echo, ultrasonic

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | Samsung Medison Co., Ltd. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | HONGCHEON-GUN Gangwon, KR |
| New listings | 13 |
| Devices | System, Imaging, Pulsed Echo, Ultrasonic; System, Imaging, Pulsed Doppler, Ultrasonic; System, Image Processing, Radiological; Transducer, Ultrasonic, Diagnostic; Automated Radiological Image Processing Software |
| Product codes | IYO, IYN, LLZ, ITX, QIH |
| Device classes | Class II |
| Medical specialties | Radiology |
| Brand names | XV10 ONE Diagnostic Ultrasound System; cV10 ONE Diagnostic Ultrasound System; XH10 Diagnostic Ultrasound System; XH10 ONE Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; HERA Z10 Diagnostic Ultrasound System; V10 ONE Diagnostic Ultrasound System; XV10 Diagnostic Ultrasound System |
| First new listing | 2026-08-03 |
| Latest new listing | 2026-10-14 |
| FDA registration number | 8041160 |
| Registration expires | 2027-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- Listed in the last 45 days.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.