V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System— 510(k) K223387
Substantially EquivalentSamsung Medison Co., Ltd.
FDA 510(k) clearance K223387 for V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System, Substantially Equivalent on 2023-02-13. Applicant: Samsung Medison Co., Ltd..
Clearance details
- Applicant
- Samsung Medison Co., Ltd.
- Product code
- Code IYN
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hongcheon-Gun, KR
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.