510(k) K873296 ยท KGI Densitometer, Bone
DPX BONE DENSITOMETER
| Applicant | Lunar Radiation Corp., Madison WI, US |
| Decision | Substantially Equivalent, Jun 6, 1988 |
| Received | Aug 17, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K873296
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 16, 2018 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LL GE Healthcare Lunar:
a) DPX NT, Model Numbers: LU8230, LU40338, LU42357, LU42369
b) DPX MD+, Model Numbers: LU8230, LU40338, LU40352
Provides an estimate of BMD (Bone Marrow Density) at the lumbar Terminated |
KGI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.