FDA Product Code KGI: Densitometer, Bone
Leading manufacturers include BunkerHill Health, Medimaps Group SA and 3D-Shaper Medical S.L.
FDA 510(k) Cleared Densitometer, Bone Devices (Product Code KGI)
About Product Code KGI - Regulatory Context
510(k) Submission Activity
147 total 510(k) submissions under product code KGI since 1979, with 147 receiving FDA clearance (average review time: 155 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under KGI have taken an average of 186 days to reach a decision - up from 155 days historically. Manufacturers should account for longer review timelines in current project planning.
KGI devices are reviewed by the Radiology panel. Browse all Radiology devices →