Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9 Pro,Nuewa R9S,Resona 7,Resona 7CV,Resona 7EXP,Resona 7S, Resona 7OB,Resona 7PRO,Imagyn 7,Resona Y Diagnostic Ultrasound System— 510(k) K202785

Clearance details

Applicant

Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.

Product code

Code IYN

Device class

Class 2

Regulation

21 CFR 892.1550

Advisory panel

Radiology

Date received

2020-09-22

Decision date

2021-04-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Shenzhen, CN

• K261313 — Vivid Explorer/Vivid Advanced/Vivid Focus2026-09-02
• 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

• K221267 — VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor2022-12-15
• K222754 — ViewMate Multi Ultrasound System2022-11-09
• K173369 — DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System2017-12-13
• K171233 — Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System2017-09-12
• K170712 — Accutorr 7/VS-900 Vital Signs Monitor2017-08-02

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 →