Data / Medical devices / Densitometer, Bone
Densitometer, Bone (KGI): 14 FDA-registered makers in 6 countries
14 establishments in 6 countries are registered with the FDA to make Densitometer, Bone (product code KGI, Class 2, 21 CFR 892.1170). 12 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 148 510(k) clearances under this code, the latest on September 11, 2026, and lists 10 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KGI
- Device class
- 2
- Regulation
- 892.1170
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Mexico | 2 |
| Germany | 2 |
| Spain | 1 |
| Switzerland | 1 |
| China | 1 |
Makers of Densitometer, Bone
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| GE Medical Systems Ultrasound & Primary Care Diagnostics LLC | Madison, WI, United States | Specification developer | 7 | April 20, 2026 | 0 | 1 | 0 | api.fda.gov |
| Ge Medical Systems Monterrey Mexico, S.A. De C.V. | APODACA Nuevo Leon, Mexico | Manufacturer | 6 | April 20, 2026 | 0 | 0 | 0 | api.fda.gov |
| Mindways Software, Inc. | Austin, TX, United States | Manufacturer | 4 | August 29, 2014 | 0 | 0 | 0 | api.fda.gov |
| 3d-Shaper Medical S.L. | Barcelona, Spain | Manufacturer | 2 | September 5, 2025 | 0 | 0 | 0 | api.fda.gov |
| Hologic, Inc. | Newark, DE, United States | Complaint file establishment, Manufacturer, Remanufacturer | 2 | March 28, 2008 | 0 | 1 | 0 | api.fda.gov |
| Medimaps Group SA | Plan-les-Ouates Geneve, Switzerland | Manufacturer | 2 | January 17, 2025 | 0 | 2 | 0 | api.fda.gov |
| Bunkerhill Health | San Francisco, CA, United States | Manufacturer | 1 | April 8, 2025 | 0 | 0 | 0 | api.fda.gov |
| Ge Hangwei Medical Systems Co., Ltd. | Beijing, China | Manufacturer | 1 | April 20, 2026 | 0 | 0 | 0 | api.fda.gov |
| Heartlung Corporation | Houston, TX, United States | Manufacturer | 1 | July 29, 2022 | 0 | 0 | 0 | api.fda.gov |
| Medsource Parts, LLC | Boulder, CO, United States | Remanufacturer | 1 | November 8, 2002 | 0 | 0 | 0 | api.fda.gov |
| O.N. Diagnostics, LLC | Berkeley, CA, United States | Manufacturer | 1 | September 13, 2012 | 0 | 0 | 0 | api.fda.gov |
| Stratec Medizintechnik GMBH | PFORZHEIM Baden-Wurttemberg, Germany | Manufacturer | 1 | October 29, 1998 | 0 | 0 | 0 | api.fda.gov |
| Flextronics Manufacturing Aguascalientes, S.A de C.V | Aguascalientes, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthineers AG | FORCHHEIM Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.