2 devices · 2 companies · 2022 to 2025
Product code KGI: Densitometer, Bone
2 devices under product code KGI, 2022 to 2025, from 2 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (2 of 2 here), the regulation, and MAUDE report counts by product code.
Densitometer, Bone. 21 CFR 892.1170, Class II. MAUDE held 59 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| BunkerHill BMDK242295 · 510(k) | BunkerHill Health | Radiology | database entry | |
| ABMD SoftwareK213760 · 510(k) | HeartLung Corporation | Radiology | database entry |
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