K252718
- 510(k) number
- K252718
- Device name
- Lunar Astra
- Applicant
- GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC WI · US
- Product code
- KGI — Densitometer, Bone
- Decision date
- 2026-04-20
- Date received
- 2025-08-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K252718.pdf
Official FDA record: K252718
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.