Diagnostic Ultrasound System (Nuewa A20W); Diagnostic Ultrasound System (Nuewa A20); Diagnostic Ultrasound System (Nuewa
Summary
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. received 510(k) clearance for 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, a IYN device. Cleared on 2026-10-16.
Details
Source
510(k) Clearance
External ID
K261585
Action Date
2026-10-16
Status
Traditional
Category
device
Product Code
IYN
Product Description
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. 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 446 device clearances issued this month. Shenzhen Mindray Bio-Medical Electronics Co., Ltd. has received 34 total clearances in our database.
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. has 34 FDA actions in our database, including 34 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 34 FDA actions in our database, including 0 recalls and 34 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K261585" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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