510(k) clearance
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
- 510(k) number
- K263182
- Applicant
- Samsung Medison Co., Ltd.
- Decision date
- Sep 25, 2026
- Date received
- Sep 11, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- IYN
- Device type
- System, Imaging, Pulsed Doppler, Ultrasonic
- Device class
- Class II
- Regulation
- 21 CFR 892.1550
- Advisory committee
- Radiology
- Statement or summary
- Summary
- Third party
- Y
- Location
- Hongcheon-Gun, KR