K251408 is an FDA 510(k) clearance for the OsteoSight™ Hip (v1). This device is classified as a Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density (Class II - Special Controls, product code SAO).
Submitted by Naitive Technologies, Ltd. (Cambridge, GB). The FDA issued a Cleared decision on September 2, 2025, 119 days after receiving the submission on May 6, 2025.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1171. 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..
| 510(k) Number | K251408 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 2025 |
| Decision Date | September 02, 2025 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | SAO - Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1171 |
| Definition | 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. |