FDA.report

510(k) K252718

Device
Lunar Astra
Applicant
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
510(k) number
K252718
Product code
KGI
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-20
Date received
2025-08-28
Regulation
892.1170
Classification name
Densitometer, Bone
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Christopher Paulik
Address
3030 Ohmeda Dr. Madison WI US 53718 53718

FDA Registration Numbers

Source Documents

510(k) summary PDF

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