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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Densitometer, Bone
510(k) Number K252718
Device Name Lunar Astra
Applicant
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
3030 Ohmeda Dr.
Madison,  WI  53718
Applicant Contact Christopher Paulik
Correspondent
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
3030 Ohmeda Dr.
Madison,  WI  53718
Correspondent Contact Christopher Paulik
Regulation Number892.1170
Classification Product Code
KGI  
Date Received08/28/2025
Decision Date 04/20/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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