BoneVue— 510(k) K254072
Substantially EquivalentCurvebeam AI / Curvebeam, LLC
FDA 510(k) clearance K254072 for BoneVue, Substantially Equivalent on 2026-09-11. Applicant: Curvebeam AI / Curvebeam, LLC. Device class: 2.
Summary
BoneVue is filed under KGI, bone densitometers, the code for devices and software that estimate bone mineral density. Curvebeam AI is best known for extremity CT scanners, so a CT-based bone assessment tool would make sense. The record itself doesn't name a modality, though.
Class II, 21 CFR 892.1170. The Radiology panel reviewed it as a Traditional 510(k).
The company filed from Hatfield, Pennsylvania, and waited 267 days (December 18, 2025 to September 11, 2026). Density claims from anything other than DXA generally need accuracy data against a reference method, and that can drag a review out.
Clearance details
- Applicant
- Curvebeam AI / Curvebeam, LLC
- Product code
- Code KGI
- Device class
- Class 2
- Regulation
- 21 CFR 892.1170
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hatfield, PA, US
Recent devices under product code KGI
view allAdverse events under product code KGI
product code KGI- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.