510(k) clearance
Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp);Diagnostic Ultrasound System (Resona I10);Diagnostic Ultrasound System (Resona I10S);Diagnostic Ultrasound System (Resona XI);Diagnostic Ultrasound System (Resona I10 CV);Diagnostic Ultrasound System (Nuewa I10W);Diagnostic Ultrasound System (Nuewa I10 Exp);Diagnostic Ultrasound System (Nuewa I10);Diagnostic Ultrasound System (Nuewa I10S);Diagnostic Ultrasound System (Nuewa XI);Diagnostic Ultrasoun
- 510(k) number
- K261617
- Applicant
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decision date
- Oct 8, 2026
- Date received
- May 15, 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