Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, NuewaI8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System— 510(k) K240115

Clearance details

Applicant

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Product code

Product code IYN

Device class

Class 2

Regulation

21 CFR 892.1550

Advisory panel

Radiology

Date received

2024-01-16

Decision date

2024-04-22

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

• 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 →