FDA 510(k)

BoneXpert

K-Number: K262390 · 2026-09-22

Decision Date2026-09-22

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

BoneXpert is the device name listed in this FDA 510(k) record. The listed applicant is Visiana. It received FDA 510(k) clearance on 2026-09-22 under 510(k) number K262390. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BoneXpert?

BoneXpert is a medical device that received FDA 510(k) clearance on 2026-09-22. The listed applicant is Visiana. The 510(k) number is K262390.

When did BoneXpert receive FDA 510(k) clearance?

BoneXpert received FDA 510(k) clearance on 2026-09-22, under 510(k) number K262390.

Who is the listed applicant for BoneXpert?

The FDA 510(k) record lists Visiana as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BoneXpert?

The FDA product code for BoneXpert is QIH.

Related Devices (Code: QIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260055syngo.CT Brain QuantificationSiemens Medical Solutions USA, Inc.K261368Rapid Platform (R6.7)Ischemaview, Inc.K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics K261677Artificial Intelligence Renal Assessment (AIRA) Version 1Aramis Global AI Consultancies, LLC K261795Quicktome Software SuiteOmniscient Neurotechnology Pty, Ltd.K2608794DMINVIA, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.