V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System— 510(k) K220975
Substantially EquivalentSamsung Medison Co., Ltd.
FDA 510(k) clearance K220975 for V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System, Substantially Equivalent on 2022-06-29. Applicant: Samsung Medison Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Samsung Medison Co., Ltd.
- Product code
- 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- K261313 — Vivid Explorer/Vivid Advanced/Vivid Focus
- K254027 — Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90)
- K261668 — Venue Go
- K262311 — Alturion Series Diagnostic Ultrasound System
- K261288 — Handheld Ultrasound Scanner
More clearances from Samsung Medison Co., Ltd.
view all- K261412 — V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System +4 more
- K254099 — EVO Q30 Diagnostic Ultrasound System +8 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.