510(k) K982267 ยท KGI Densitometer, Bone
DPX-RX BONE DENSITOMETER
| Applicant | Lunar Corp., Madison WI, US |
| Decision | Substantially Equivalent, Aug 18, 1998 |
| Received | Jun 29, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982267
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 16, 2018 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LL GE Healthcare:
a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431, LU40626, LU40637, LU40626, LU40637, LU42021, LU42025, LU41730, LU41734, LU42344, LU42365
b) Prodigy Advanced, Model Number Terminated |
KGI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.