K012389
Substantially EquivalentREVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM
- Applicant
- Ge Medical Systems, Inc.
- Product code
- KPR
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Milwaukee, WI, 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.