LUNAR IDXA— 510(k) K052581
Substantially EquivalentGe Medical Systems Ultrasound and Primary Care Dia
FDA 510(k) clearance K052581 for LUNAR IDXA, Substantially Equivalent on 2005-10-20. Applicant: Ge Medical Systems Ultrasound and Primary Care Dia.
Clearance details
- Applicant
- Ge Medical Systems Ultrasound and Primary Care Dia
- Product code
- Code KGI
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- 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.