Device Listing 1099597214

Listing Summary#

Listing key
1099597214
Premarket submission
K254099
Device
EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ30 Diagnostic Ultrasound System; EVO XQ20 Diagnostic Ultrasound System; EVO XQ10 Diagnostic Ultrasound System; EVO QH30 Diagnostic Ultrasound System; EVO QH20 Diagnostic Ultrasound System; EVO QH10 Diagnostic Ultrasound System
Applicant
Samsung Medison Co., Ltd.
Product code
IYN
Decision date
2026-03-27