Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp);Diagnostic Ultrasound System (R
Summary
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. received 510(k) clearance for 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, a IYN device. Cleared on 2026-10-08.
Details
Source
510(k) Clearance
External ID
K261617
Action Date
2026-10-08
Status
Traditional
Category
device
Product Code
IYN
Product Description
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. Product code: IYN.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 502 device clearances issued this month. Shenzhen Mindray Bio-Medical Electronics Co., Ltd. has received 35 total clearances in our database.
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. has 35 FDA actions in our database, including 35 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Shenzhen Mindray Bio-Medical Electronics Co., Ltd. have FDA actions?
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. has 35 FDA actions in our database, including 0 recalls and 35 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K261617" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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