FDA product code KGI: Densitometer, Bone
KGI is the FDA product code for densitometer, bone. It is a Class II device, regulated under 21 CFR 892.1170 and reviewed by the Radiology panel. FDA has cleared 148 510(k) submissions under KGI, 8 in the last five years, from 44 different applicants. The average 510(k) review took 156 days (median 123); 210 days on average over the last three years. FDA has posted 26 recalls for KGI devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Densitometer, Bone |
| Device class | Class II |
| Regulation | 21 CFR 892.1170 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KGI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 25 |
| 2019 | 1 | 146 |
| 2022 | 2 | 252 |
| 2023 | 1 | 462 |
| 2025 | 3 | 170 |
| 2026 | 2 | 251 |
Compare with all 510(k) review times · Search every KGI clearance
Top KGI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hologic, Inc. | 29 | 2013-05-31 |
| Lunar Corp. | 20 | 2000-07-10 |
| Norland Corp. | 15 | 1998-06-12 |
| Image Analysis, Inc. | 7 | 2003-07-30 |
| Lunar | 6 | 1992-02-27 |
39 more applicants have KGI clearances. See the full list in Caduvo.
Most recent KGI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254072 | Curvebeam AI / Curvebeam, LLC | BoneVue | 2026-09-11 | 267 |
| K252718 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | Lunar Astra | 2026-04-20 | 235 |
| K251022 | 3D-Shaper Medical S.L | 3D-SHAPER | 2025-09-05 | 156 |
| K242295 | BunkerHill Health | BunkerHill BMD | 2025-04-08 | 249 |
| K243218 | Medimaps Group SA | TBS iNsight (V4) | 2025-01-17 | 105 |
Recalls for KGI devices
26 product recalls in 10 recall events; 2 initiated in the last five years and 6 still open. Most recent: 2025-02-03.
| Year | Recalls |
|---|---|
| 2018 | 3 |
| 2019 | 4 |
| 2024 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code KGI?
KGI is the FDA product code for densitometer, bone. It is a Class II device, regulated under 21 CFR 892.1170 and reviewed by the Radiology panel.
What device class is KGI?
Class II, regulation 21 CFR 892.1170. Typical premarket route: 510(k).
How long does a 510(k) take for product code KGI?
Across 148 cleared submissions the average was 156 days from receipt to decision (median 123).
Which companies have the most KGI clearances?
Hologic, Inc. (29); Lunar Corp. (20); Norland Corp. (15); Image Analysis, Inc. (7); Lunar (6).
Have KGI devices been recalled?
Yes: 26 product recalls across 10 recall events; the most recent began 2025-02-03.
Next steps
- Run an FDA pathway report with predicate devices for product code KGI
- Run a recall and safety report across every KGI manufacturer
- Watch product code KGI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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