KGI
- Product code
- KGI
- Device name
- Densitometer, Bone
- Device class
- Class 2
- 21 CFR
- 21 CFR 892.1170
- Medical specialty
- Radiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 4
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 147 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252718 | 2026-04-20 | GE Medical Systems Ultrasound & Primar… | Lunar Astra | |
| K251022 | 2025-09-05 | 3D-Shaper Medical S.L | 3D-SHAPER | |
| K242295 | 2025-04-08 | BunkerHill Health | BunkerHill BMD | |
| K243218 | 2025-01-17 | Medimaps Group SA | TBS iNsight (V4) |
Official FDA classification page: KGI
Classification and pathway per current FDA publications. Data from openFDA (CC0).