EVO Q30 Diagnostic Ultrasound System +8 more— 510(k) K254099
Substantially EquivalentSamsung Medison Co., Ltd.
FDA 510(k) clearance K254099 for EVO Q30 Diagnostic Ultrasound System +8 more, Substantially Equivalent on 2026-03-27. Applicant: Samsung Medison Co., Ltd.. Device class: 2.
Summary
Samsung Medison's record lists nine EVO Diagnostic Ultrasound Systems: Q30, Q20, Q10, XQ30, XQ20, XQ10, QH30, QH20 and QH10. All are filed under IYN, pulsed Doppler ultrasonic imaging systems.
Class II, 21 CFR 892.1550. Radiology is both the classification panel and the review panel. It was a Traditional 510(k).
Samsung Medison filed from Hongcheon-Gun, South Korea. The decision came 98 calendar days after receipt (December 19, 2025 to March 27, 2026).
Clearance details
- Device name as filed
- 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
- Product code IYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.1550
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hongcheon-Gun, KR
Recent devices under product code IYN
view all- K261585 — Diagnostic Ultrasound System (Nuewa A20W) +10 more
- K261617 — Diagnostic Ultrasound System (11+ models)
- K263150 — V10 Diagnostic Ultrasound System +10 more
- K261933 — Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
- K262548 — EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
More clearances from Samsung Medison Co., Ltd.
view all- K263182 — EVO X30 Diagnostic Ultrasound System +8 more
- K261412 — V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System +4 more
- K252018 — HERA Z20 Diagnostic Ultrasound System +5 more
- K250999 — V8 Diagnostic Ultrasound System +9 more
- K243702 — V8 Diagnostic Ultrasound System +5 more
Adverse events under product code IYN
product code IYN- Death
- 25
- Injury
- 163
- Malfunction
- 1,538
- Other
- 4
- Total
- 1,730
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.