Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9); Diagnostic Ultrasound System (Recho R
Summary
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. received 510(k) clearance for Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9); Diagnostic Ultrasound System (Recho R9 Pro); Diagnostic Ultrasound System (Recho R9 Exp); Diagnostic Ultrasound System (Recho R9S); Diagnostic Ultrasound System (Recho R9T); Diagnostic Ultrasound System (Crius R9 CV); Diagnostic Ultrasound System (Anesus R9 CV); Diagnostic Ultrasound System (Recho R9 Super); Diagnostic Ultrasound System (Recho R9 Lumi); Diagnostic Ultrasound System (Recho R CV); Diagnost, a IYN device. Cleared on 2025-05-19.
Details
Source
510(k) Clearance
External ID
K250020
Action Date
2025-05-19
Status
Traditional
Category
device
Product Code
IYN
Product Description
Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9); Diagnostic Ultrasound System (Recho R9 Pro); Diagnostic Ultrasound System (Recho R9 Exp); Diagnostic Ultrasound System (Recho R9S); Diagnostic Ultrasound System (Recho R9T); Diagnostic Ultrasound System (Crius R9 CV); Diagnostic Ultrasound System (Anesus R9 CV); Diagnostic Ultrasound System (Recho R9 Super); Diagnostic Ultrasound System (Recho R9 Lumi); Diagnostic Ultrasound System (Recho R CV); Diagnost. 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 "K250020" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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