FDA device listing
Anesus I9 Easi/Eagus I9 Diagnostic Ultrasound System,Imagyn I9S/Imagyn I9 Easi/Nuewa I9/Nuewa I9S Diagnostic Ultrasound…
FDA device listing 2038232827 · SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
Key facts
| Proprietary names | Anesus I9 Easi/Eagus I9 Diagnostic Ultrasound System,Imagyn I9S/Imagyn I9 Easi/Nuewa I9/Nuewa I9S Diagnostic Ultrasound System,Nuewa I9T/Nuewa I9 Exp/Nuewa I9 Easi/Anesus I9 Diagnostic Ultrasound System,Resona I9 Easi/Resona I9 Nasa/Resona IV/Imagyn I9 Diagnostic Ultrasound System,Resona I9/Resona I9 Exp/Resona I9S/Resona I9T Diagnostic Ultrasound System,Resona I9W Diagnostic Ultrasound System |
|---|---|
| Owner/operator | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| Owner/operator number | 9058402 |
| Premarket submissions | K210699 |
| 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 | Shenzhen Mindray Bio-Medical Electronics Co.,LTD, SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. |
| Establishment registrations | 3007603826, 3009156722 |
| FEI numbers | 3007603826, 3009156722 |
| Establishment operations | Foreign Exporter, Specification Developer, 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