510(k) K133664 ยท KGI Densitometer, Bone
ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS
| Applicant | Ge Medical Systems Ultrasound & Primary Care Diagn, Madison WI, US |
| Decision | Substantially Equivalent, May 15, 2014 |
| Received | Nov 29, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133664
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2020 | GE Healthcare, LLC Lunar iDXA Advance (iDXA with enCORE v16) 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.