M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System
Summary
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. received 510(k) clearance for M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System, a IYN device. Cleared on 2023-06-09.
Details
Source
510(k) Clearance
External ID
K230768
Action Date
2023-06-09
Status
Traditional
Category
device
Product Code
IYN
Product Description
M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System. 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 403 device clearances issued this month. Shenzhen Mindray Bio-Medical Electronics Co., Ltd. has received 32 total clearances in our database.
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. has 32 FDA actions in our database, including 32 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 32 FDA actions in our database, including 0 recalls and 32 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K230768" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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