510(k) clearance
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
- 510(k) number
- K261585
- Applicant
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decision date
- Oct 16, 2026
- Date received
- May 13, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- IYN
- Device type
- System, Imaging, Pulsed Doppler, Ultrasonic
- Device class
- Class II
- Regulation
- 21 CFR 892.1550
- Advisory committee
- Radiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Shenzhen, CN