510(k) K030962 ยท KGI Densitometer, Bone
DPX SERIES BRAVO DUO BONE DENSITOMETER
| Applicant | Ge Lunar Corp., Madison WI, US |
| Decision | Substantially Equivalent, Jul 25, 2003 |
| Received | Mar 27, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030962
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 16, 2018 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LL GE Healthcare Lunar:
a) DPX Duo, Model Number: LU41693
b) DPX Bravo, Model Number: LU41692
Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal femur regions. This BMD Terminated |
KGI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.