DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A— 510(k) K123106
Substantially EquivalentSamsung Electronics Co., Ltd.
FDA 510(k) clearance K123106 for DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A, Substantially Equivalent on 2013-06-20. Applicant: Samsung Electronics Co., Ltd..
Clearance details
- Applicant
- Samsung Electronics Co., Ltd.
- Product code
- Code KPR
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Echo, OR, US
Adverse events under product code KPR
product code KPR- Other
- 6
- Total
- 6
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.