BoneXpert— 510(k) K262390

Name: FDA 510(k) clearance K262390
Creator: U.S. Food and Drug Administration
Published: 2026-09-22

Substantially Equivalent

Visiana

FDA 510(k) clearance K262390 for BoneXpert, Substantially Equivalent on 2026-09-22. Applicant: Visiana. Device class: 2.

Summary

BoneXpert from Visiana is filed under QIH, automated radiological image processing software. The record doesn't describe what the software measures or which images it analyzes.

Class II, 21 CFR 892.2050. The Radiology panel reviewed it as a Traditional 510(k).

Visiana filed from Horsholm, Denmark. Review took 71 days (July 13 to September 22, 2026).

Clearance details

Applicant: Visiana
Product code: Product code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2026-07-13
Decision date: 2026-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Horsholm, DK

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.