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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 K261512
Device Name OsteoSight Spine (v1)
Applicant
Naitive Technologies, Ltd.
C/O Mishcon De Reya
Four Station Sq.
Cambridge,  GB CB1 2GE
Applicant Contact Ioan Wigley
Correspondent
Naitive Technologies, Ltd.
C/O Mishcon De Reya
Four Station Sq.
Cambridge,  GB CB1 2GE
Correspondent Contact Ioan Wigley
Classification Product Code
SAO  
Date Received05/07/2026
Decision Date 10/27/2026
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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