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 record doesn't describe the device or name an imaging modality.
Class II, 21 CFR 892.1170. The Radiology panel reviewed it as a Traditional 510(k).
Curvebeam AI filed from Hatfield, Pennsylvania, and waited 267 days (December 18, 2025 to September 11, 2026).
Clearance details
- Applicant
- Curvebeam AI / Curvebeam, LLC
- Product code
- Product 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.