510(k) K161682— GE Lunar DXA Bone Densitometers with enCORE version 17
Substantially EquivalentGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
Clearance details
- Applicant
- GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
- Product code
- Code KGI
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Madison, WI, US
Adverse events under product code KGI
product code KGI- Other
- 1
- Total
- 1
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.