X-Cube 70— 510(k) K200450
Substantially EquivalentAlpinion Medical Systems Co., Ltd.
FDA 510(k) clearance K200450 for X-Cube 70, Substantially Equivalent on 2020-07-10. Applicant: Alpinion Medical Systems Co., Ltd..
Clearance details
- Applicant
- Alpinion Medical Systems Co., Ltd.
- Product code
- Code IYN
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Anyang-Si, 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.