Lunar Astra— 510(k) K252718
Substantially EquivalentGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
FDA 510(k) clearance K252718 for Lunar Astra, Substantially Equivalent on 2026-04-20. Applicant: GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. Device class: 2.
Summary
Lunar Astra, from GE Medical Systems Ultrasound & Primary Care Diagnostics, is filed under product code KGI (Densitometer, Bone). The record doesn't describe the device beyond its name and that code name.
Class II, 21 CFR 892.1170. Radiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
GE Medical Systems Ultrasound & Primary Care Diagnostics filed from Madison, Wisconsin. The record shows 235 calendar days from receipt to decision (August 28, 2025 to April 20, 2026).
Clearance details
- Applicant
- GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
- Product code
- Product code KGI
- Device class
- Class 2
- Regulation
- 21 CFR 892.1170
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Madison, WI, US
Recent devices under product code KGI
view allMore clearances from GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
view allAdverse 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.