DIGITAL RADIOGRAPHY SYSTEM, MODELS GALAXY 900 AND 1600— 510(k) K093816
Substantially EquivalentMedien International Co, Ltd.
FDA 510(k) clearance K093816 for DIGITAL RADIOGRAPHY SYSTEM, MODELS GALAXY 900 AND 1600, Substantially Equivalent on 2010-10-05. Applicant: Medien International Co, Ltd..
Clearance details
- Applicant
- Medien International 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.