FDA device listing
Apogee C1,Apogee C2,Apogee C3,Apogee C5,Apogee K1,Apogee K2,Apogee K3,Apogee K5,Apogee U1,Apogee U2,Apogee U3,Apogee U5
FDA device listing 1572513384 · SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD.
Key facts
| Proprietary names | Apogee C1,Apogee C2,Apogee C3,Apogee C5,Apogee K1,Apogee K2,Apogee K3,Apogee K5,Apogee U1,Apogee U2,Apogee U3,Apogee U5 |
|---|---|
| Owner/operator | SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD. |
| Owner/operator number | 9011618 |
| Premarket submissions | K243178 |
| Product codes | ITX, IYN, IYO |
| Device names | ITX - Transducer, Ultrasonic, Diagnostic, IYN - System, Imaging, Pulsed Doppler, Ultrasonic, IYO - System, Imaging, Pulsed Echo, Ultrasonic |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.1550, 892.1560, 892.1570 |
| Review panels | Radiology |
| Registered establishments | SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD. |
| Establishment registrations | 9615439, 3017944270 |
| FEI numbers | 3003861317, 3017944270 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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