# Diagnostic Ultrasound System (Nuewa A20W); Diagnostic Ultrasound System (Nuewa A20); Diagnostic Ultrasound System (Nuewa A20 Exp); Diagnostic Ultrasound System (Nuewa A20 Elite); Diagnostic Ultrasound System (Nuewa A20Q); Diagnostic Ultrasound System (Nuewa A MV); Diagnostic Ultrasound System (Nuewa

**Predicate Speed & CAPA Advisory Opportunity Score:** 48/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261585 |
| Device | Diagnostic Ultrasound System (Nuewa A20W); Diagnostic Ultrasound System (Nuewa A20); Diagnostic Ultrasound System (Nuewa A20 Exp); Diagnostic Ultrasound System (Nuewa A20 Elite); Diagnostic Ultrasound System (Nuewa A20Q); Diagnostic Ultrasound System (Nuewa A MV); Diagnostic Ultrasound System (Nuewa A Elite); Diagnostic Ultrasound System (Nuewa A MS); Diagnostic Ultrasound System (Nuewa A20 Premium); Diagnostic Ultrasound System (Nuewa A20 Plus); Diagnostic Ultrasound System (Nuewa A18 |
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
| Specialty / panel | Radiology |
| Product code | IYN |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-05-13 |
| Decision date | 2026-10-16 |
| Review time (days) | 156 |
| Third-party review | No |
| Applicant location | Shenzhen, CN |

## Why this score
- 156-day review, longer than typical.
- Posted 19 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261585). Last refreshed: 2026-11-03T18:05:14.713Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.