510(k) K992125 ยท KGI Densitometer, Bone
XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46
| Applicant | Norland Medical Systems, Inc., Fort Atkinson WI, US |
| Decision | Substantially Equivalent, Nov 22, 1999 |
| Received | Jun 23, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992125
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2011 | Cooper Surgical, Inc. DICOM Option for the Norland Illuminatus Software Revs 4.2.0 though 4.3.1. Models Norland XR-600, XR-800, XR-46, EXCELL, XR-36 and Eclipse DXA Bone Densitometers.
The XR 46 performs DXA scans of the Terminated |
KGI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.