510(k) K161682 ยท KGI Densitometer, Bone
GE Lunar DXA Bone Densitometers with enCORE version 17
| Applicant | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC, Madison WI, US |
| Decision | Substantially Equivalent, Dec 2, 2016 |
| Received | Jun 17, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161682
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2020 | GE Healthcare, LLC Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v17) 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.