Samsung Medison Co., Ltd. · Class II · Cleared Mar 27, 2026
| K-number | K254099 |
| Device name | 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 |
| Device class | Class II |
| Decision date | Mar 27, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 892.1550 |
The EVO Q30, Q20, Q10, XQ30, XQ20, XQ10, QH30, QH20, and QH10 are portable/mobile diagnostic ultrasound systems designed to acquire and display ultrasound images in multiple modes (2D, Doppler, M-mode, 3D/4D, etc.) for clinical diagnosis across diverse applications including fetal, abdominal, cardiac, pediatric, and vascular imaging. These are prescription devices intended for use by qualified healthcare professionals in hospitals, clinics, and private practices.
The proposed devices employ the same fundamental ultrasound technology as the predicate HM70 EVO system. Key additions include: intra-operative and thoracic clinical applications, MV-Flow mode, multiple transmit channels, new accessories (Video Output Device, Pencil Gender, WLAN Adapter), new software features (IDEA, IETA, EzPictogram, Voice Command, EzGuide, EzDiagram, MirrorTouch, TouchSign), seven new probes, and WLAN support with Wi-Fi and Bluetooth modules.
The devices comply with IEC 60601-1 (general safety), IEC 60601-1-2 (electromagnetic disturbances), IEC 60601-2-37 (ultrasonic diagnostic equipment), IEC 60601-2-18 (endoscopic equipment), ISO 10993-1 (biocompatibility), ISO 14971 (risk management), and NEMA UD 2-2004 (acoustic output measurement).
The proposed EVO systems are substantially equivalent to the predicate HM70 EVO because they share identical intended use (diagnostic ultrasound imaging and fluid analysis), employ the same fundamental scientific technology, have comparable safety/effectiveness supported by non-clinical testing, and maintain equivalent measurement and reporting capabilities. New features and probes do not alter the fundamental safety or effectiveness profile compared to the predicate.
View the full FDA submission: accessdata.fda.gov