Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic Ultrasound Sysem, Nuewa R9 Pro/ Nuewa R9S/ Resona 7/ Resona 7CV/Resona 7EXP/Resona 7S/ Resona 70B Diagnostic Ultrasound System, Resona 7PRO/Imagyn 7/ Resona Y/Resona R9W/Resona R7W Nuewa R9W/Nuewa R7W Diagnostic Ultrasound System (K222928)
Description
Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic Ultrasound Sysem, Nuewa R9 Pro/ Nuewa R9S/ Resona 7/ Resona 7CV/Resona 7EXP/Resona 7S/ Resona 70B Diagnostic Ultrasound System, Resona 7PRO/Imagyn 7/ Resona Y/Resona R9W/Resona R7W Nuewa R9W/Nuewa R7W Diagnostic Ultrasound System by Shenzhen Mindray Bio-Medical Electronics Co., Ltd., an FDA 510(k) cleared radiology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222928
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic Ultrasound Sysem, Nuewa R9 Pro/ Nuewa R9S/ Resona 7/ Resona 7CV/Resona 7EXP/Resona 7S/ Resona 70B Diagnostic Ultrasound System, Resona 7PRO/Imagyn 7/ Resona Y/Resona R9W/Resona R7W Nuewa R9W/Nuewa R7W Diagnostic Ultrasound System (K222928) cites 7 predicate devices and is itself cited by 6 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212704 | Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti... | Philips Medical Systems | 2021 |
| K211488 | LOGIQ E10 | GE Healthcare | 2021 |
| K210699 | Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9... | Shenzhen Mindray Bio-Medical Electr... | 2021 |
| K202785 | Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,... | Shenzhen Mindray Bio-Meidcal Electr... | 2021 |
| K200643 | Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus... | Shenzhen Mindray Bio-Medical Electr... | 2020 |
| K192159 | Voluson E6, Voluson E8, Voluson E10 | GE Healthcare | 2019 |
| K100931 | MYLABTWICE, MODEL 6200 | Esaote, S.p.A. | 2010 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250020 | Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultras... | Shenzhen Mindray Bio-Medical Electr... | 2025 |
| K242231 | Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Reso... | Shenzhen Mindray Bio-Medical Electr... | 2024 |
| K240684 | Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9... | Shenzhen Mindray Bio-Medical Electr... | 2024 |
| K233841 | HD80 Series Ultrasound Diagnostic System | Qingdao Hisense Medical Equipment C... | 2024 |
| K240115 | Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8... | Shenzhen Mindray Bio-Medical Electr... | 2024 |
| K233439 | HD60 Series Ultrasound Diagnostic System | Qingdao Hisense Medical Equipment C... | 2024 |
Trace the full predicate network for K222928
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.