GALAXY AND GALAXY+PLUS DIGITAL RADIOGRAPHY SYSTEMS— 510(k) K132294
Substantially EquivalentRadiology Solutions, LLC
FDA 510(k) clearance K132294 for GALAXY AND GALAXY+PLUS DIGITAL RADIOGRAPHY SYSTEMS, Substantially Equivalent on 2013-11-12. Applicant: Radiology Solutions, LLC.
Clearance details
- Applicant
- Radiology Solutions, LLC
- Product code
- Code KPR
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Naples, FL, 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.