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— 510(k) K222928

Clearance details

Applicant

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Product code

Code IYN

Device class

Class 2

Regulation

21 CFR 892.1550

Advisory panel

Radiology

Date received

2022-09-26

Decision date

2023-02-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Shenzhen, CN

• K254027 — Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90)2026-08-24
• K261668 — Venue Go2026-08-07
• K262311 — Alturion Series Diagnostic Ultrasound System2026-08-04
• K261288 — Handheld Ultrasound Scanner2026-07-30
• K261835 — LOGIQ Focus2026-07-30

• K253330 — A5 Anesthesia System (A5); A7 Anesthesia System (A7)2026-06-25
• K260098 — ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)2026-05-20
• K260846 — Diagnostic Ultrasound System (13+ models)2026-05-11
• K253170 — uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors2026-04-16
• K252182 — SV70 Ventilator (SV70)2026-04-06

Death

25

Injury

163

Malfunction

1,538

Other

4

Total

1,730

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →