510(k) clearance
BoneXpert
- 510(k) number
- K262390
- Applicant
- Visiana
- Decision date
- Sep 22, 2026
- Date received
- Jul 13, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- QIH
- Device type
- Automated Radiological Image Processing Software
- Device class
- Class II
- Regulation
- 21 CFR 892.2050
- Advisory committee
- Radiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Horsholm, DK