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510(k) K251408

OsteoSight™ Hip (v1) by Naitive Technologies, Ltd. — Product Code SAO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2025
Date Received
May 6, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
Device Class
Class II
Regulation Number
892.1171
Review Panel
RA
Submission Type

This device is software which opportunistically assesses radiological images to estimate bone mineral density (BMD) intended to assist in a healthcare professional's decision to evaluate patients for possible low BMD within a bone health screening program. The software employs an algorithm that estimates BMD using eligible radiological image data obtained for other clinical purposes.

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