FDA 510(k)

BoneVue

K-Number: K254072 · 2026-09-11

Decision Date2026-09-11

Product CodeKGI

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

BoneVue is the device name listed in this FDA 510(k) record. The listed applicant is Curvebeam AI / Curvebeam, LLC. It received FDA 510(k) clearance on 2026-09-11 under 510(k) number K254072. The device is classified under product code KGI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BoneVue?

BoneVue is a medical device that received FDA 510(k) clearance on 2026-09-11. The listed applicant is Curvebeam AI / Curvebeam, LLC. The 510(k) number is K254072.

When did BoneVue receive FDA 510(k) clearance?

BoneVue received FDA 510(k) clearance on 2026-09-11, under 510(k) number K254072.

Who is the listed applicant for BoneVue?

The FDA 510(k) record lists Curvebeam AI / Curvebeam, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BoneVue?

The FDA product code for BoneVue is KGI.

Related Devices (Code: KGI)

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.

K252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC K2510223D-SHAPER3D-Shaper Medical S.L K242295BunkerHill BMDBunkerHill Health K243218TBS iNsight (V4)Medimaps Group SA K220402VirtuOstO.N. Diagnostics K2208223D-SHAPER3D-Shaper Medical S.L

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.