FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Lunar Astra
K Number: K252718
·
Decision Apr 20, 2026
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
146
Applicant Total
14
Review Days
235
Basic Information
- Device Name
- Lunar Astra
- K Number
- K252718
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1170
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
- Date Received
- August 28, 2025
- Decision Date
- April 20, 2026
- Product Code
- KGI
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KGI | Densitometer, Bone | FDA class 2 | Radiology |
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| K161682 | GE Lunar DXA Bone Densitometers with enCORE version 17 | Dec 2, 2016 | Substantially Equivalent |