FDA device listing
HERA Z20,HERA Z20e,HERA Z20s,HERA Z30,R20,R30,Z20
FDA device listing 2019287039 · SAMSUNG MEDISON CO., LTD.
Key facts
| Proprietary names | HERA Z20,HERA Z20e,HERA Z20s,HERA Z30,R20,R30,Z20 |
|---|---|
| Owner/operator | SAMSUNG MEDISON CO., LTD. |
| Owner/operator number | 8041160 |
| Premarket submissions | K241971 |
| Product codes | ITX, IYN, IYO, QIH |
| Device names | ITX - Transducer, Ultrasonic, Diagnostic, IYN - System, Imaging, Pulsed Doppler, Ultrasonic, IYO - System, Imaging, Pulsed Echo, Ultrasonic, 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
- 1–9 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