HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System— 510(k) K192319
Substantially EquivalentSamsung Medison Co., Ltd.
FDA 510(k) clearance K192319 for HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System, Substantially Equivalent on 2019-12-10. Applicant: Samsung Medison Co., Ltd.. Device class: 2.
Clearance details
- 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
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- 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
- K254099 — EVO Q30 Diagnostic Ultrasound System +8 more
- K252018 — HERA Z20 Diagnostic Ultrasound System +5 more
- K250999 — V8 Diagnostic Ultrasound System +9 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.