FDA device listing
Apogee 1000,Apogee 1000B/W,Apogee 1000Exp,Apogee 1000Lite,Apogee 1000Neo,Apogee 1G,Apogee 1T,Apogee 1U
FDA device listing 1470233731 · SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD.
Key facts
| Proprietary names | Apogee 1000,Apogee 1000B/W,Apogee 1000Exp,Apogee 1000Lite,Apogee 1000Neo,Apogee 1G,Apogee 1T,Apogee 1U |
|---|---|
| Owner/operator | SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD. |
| Owner/operator number | 9011618 |
| Premarket submissions | K210317 |
| 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