FDA device listing
HERA W12 Diagnostic Ultrasound System,HERA W12 Elite Diagnostic Ultrasound System,HERA W12 Plus Diagnostic Ultrasound…
FDA device listing 1870412191 · SAMSUNG MEDISON CO., LTD.
Key facts
| Proprietary names | HERA W12 Diagnostic Ultrasound System,HERA W12 Elite Diagnostic Ultrasound System,HERA W12 Plus Diagnostic Ultrasound System,HERA W20 Diagnostic Ultrasound System,HERA W20 Elite Diagnostic Ultrasound System,HERA W20 Plus Diagnostic Ultrasound System,HERA W30 Diagnostic Ultrasound System,HERA W30 Elite Diagnostic Ultrasound System,HERA W30 Plus Diagnostic Ultrasound System,HERA XW12 Diagnostic… |
|---|---|
| Owner/operator | SAMSUNG MEDISON CO., LTD. |
| Owner/operator number | 8041160 |
| Premarket submissions | K252018 |
| Product codes | ITX, IYN, IYO, LLZ, QIH |
| Device names | ITX - Transducer, Ultrasonic, Diagnostic, IYN - System, Imaging, Pulsed Doppler, Ultrasonic, IYO - System, Imaging, Pulsed Echo, Ultrasonic, LLZ - System, Image Processing, Radiological, QIH - Automated Radiological Image Processing Software |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.1550, 892.1560, 892.1570, 892.2050 |
| Review panels | Radiology |
| Registered establishments | SAMSUNG MEDISON CO., LTD. |
| Establishment registrations | 8041160, 3009758186 |
| FEI numbers | 3009758186, 3010289997 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database