510(k) K251408
K251408 is an FDA 510(k) premarket notification submitted by Naitive Technologies, Ltd. for the device "OsteoSight Hip (v1)". The FDA issued a decision of Substantially Equivalent on Sep 2, 2025. The device falls under product code SAO (Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density), a Class II device regulated under 21 CFR 892.1171.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 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.