510(k) K251408
- Device
- OsteoSight™ Hip (v1)
- Applicant
- Naitive Technologies, Ltd.
- 510(k) number
- K251408
- Product code
- SAO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-09-02
- Date received
- 2025-05-06
- Regulation
- 892.1171
- Classification name
- Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Ioan Wigley
- Address
- C/O Mishcon De Reya Four Station Sq. Cambridge GB CB1 2GE CB1 2GE
FDA Registration Numbers#
- 3041277558
- 3033583855
Source Documents#
Other 510(k) Records For Product Code SAO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN230023 | Rho | 16 Bit, Inc. | 2024-04-09 |