510(k) K191112 ยท KGI Densitometer, Bone
GEHC DXA Bone Densitometers with enCORE version 18
| Applicant | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC, Madison WI, US |
| Decision | Substantially Equivalent, Sep 19, 2019 |
| Received | Apr 26, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191112
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2020 | GE Healthcare, LLC Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer Open, Classified |
KGI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.