Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System— 510(k) K171233

Clearance details

Applicant

Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.

Product code

Product code IYN

Device class

Class 2

Regulation

21 CFR 892.1550

Advisory panel

Radiology

Date received

2017-04-27

Decision date

2017-09-12

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Shenzhen, CN

• K261585 — Diagnostic Ultrasound System (Nuewa A20W) +10 more2026-10-16
• K261617 — Diagnostic Ultrasound System (11+ models)2026-10-08
• K263150 — V10 Diagnostic Ultrasound System +10 more2026-10-08
• K261933 — Voluson Expert 18; Voluson Expert 20; Voluson Expert 222026-10-02
• K262548 — EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System2026-09-25

• 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
• K202785 — 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 System2021-04-08
• K173369 — DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System2017-12-13
• 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 →