EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP
Summary
Samsung Medison Co., Ltd. received 510(k) clearance for EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP30 Diagnostic Ultrasound System; EVO XP20 Diagnostic Ultrasound System; EVO XP10 Diagnostic Ultrasound System; EVO XC30 Diagnostic Ultrasound System; EVO XC20 Diagnostic Ultrasound System; EVO XC10 Diagnostic Ultrasound System, a IYN device. Cleared on 2026-09-25.
Details
Source
510(k) Clearance
External ID
K263182
Action Date
2026-09-25
Status
Traditional
Category
device
Product Code
IYN
Product Description
EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP30 Diagnostic Ultrasound System; EVO XP20 Diagnostic Ultrasound System; EVO XP10 Diagnostic Ultrasound System; EVO XC30 Diagnostic Ultrasound System; EVO XC20 Diagnostic Ultrasound System; EVO XC10 Diagnostic Ultrasound System. Product code: IYN.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 445 device clearances issued this month. Samsung Medison Co., Ltd. has received 18 total clearances in our database.
Samsung Medison Co., Ltd. has 18 FDA actions in our database, including 18 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 Samsung Medison Co., Ltd. have FDA actions?
Samsung Medison Co., Ltd. has 18 FDA actions in our database, including 0 recalls and 18 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K263182" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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