Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K240684
Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9, Resona I9W, Recho I9, Recho I9 Pro, Recho I9 Exp, Recho I9S, Recho I9T Diagnostic Ultrasound System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · decided 2024-06-17 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Resona IV Diagnostic Ultrasound System | Resona IV | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 06936415980870 |
| Recho I9 Pro Diagnostic Ultrasound System | Recho I9 Pro | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 06903053044035 |
| Resona I9 Easi Diagnostic Ultrasound System | Resona I9 Easi | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 06936415980825 |
| Recho I9T Diagnostic Ultrasound System | Recho I9T | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 06903053044066 |
| Anesus I9 Easi Diagnostic Ultrasound System | Anesus I9 Easi | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 06936415980733 |
| Resona I9T Diagnostic Ultrasound System | Resona I9T | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 06936415980863 |
| Eagus I9 Diagnostic Ultrasound System | Eagus I9 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 06936415980740 |
| Recho I9S Diagnostic Ultrasound System | Recho I9S | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 06903053044059 |
| Resona I9W Diagnostic Ultrasound System | Resona I9W | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 06936415987978 |
| Imagyn I9 Diagnostic Ultrasound System | Imagyn I9 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 06936415980757 |
| Imagyn I9S Diagnostic Ultrasound System | Imagyn I9S | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 06936415980771 |
| Imagyn I9 Easi Diagnostic Ultrasound System | Imagyn I9 Easi | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 06936415980764 |
| Nuewa I9T Diagnostic Ultrasound System | Nuewa I9T | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 06936415986216 |
| Nuewa I9 Easi Diagnostic Ultrasound System | Nuewa I9 Easi | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 06936415980795 |
| Resona I9 Exp Diagnostic Ultrasound System | Resona I9 Exp | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 06936415980832 |
| Nuewa I9S Diagnostic Ultrasound System | Nuewa I9S | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 06936415980801 |
| Nuewa I9 Diagnostic Ultrasound System | Nuewa I9 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 06936415980788 |
| Resona I9 Nasa Diagnostic Ultrasound System | Resona I9 Nasa | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 06936415980849 |
| Resona I9 Diagnostic Ultrasound System | Resona I9 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 06936415980818 |
| Anesus I9 Diagnostic Ultrasound System | Anesus I9 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 06936415980726 |
| Nuewa I9 Exp Diagnostic Ultrasound System | Nuewa I9 Exp | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 06936415986209 |
| Recho I9 Diagnostic Ultrasound System | Recho I9 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 06903053044028 |
| Resona I9S Diagnostic Ultrasound System | Resona I9S | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 06936415980856 |
| Recho I9 Exp Diagnostic Ultrasound System | Recho I9 Exp | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | IYN | 06903053044042 |