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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
510(k) Number K251408
Device Name OsteoSight™ Hip (v1)
Applicant
Naitive Technologies, Ltd.
C/O Mishcon De Reya
Four Station Square
Cambridge,  GB CB1 2GE
Applicant Contact Ioan Wigley
Correspondent
Naitive Technologies, Ltd.
C/O Mishcon De Reya
Four Station Square
Cambridge,  GB CB1 2GE
Correspondent Contact Ioan Wigley
Classification Product Code
SAO  
Date Received05/06/2025
Decision Date 09/02/2025
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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