510(k) K072847 ยท KGI Densitometer, Bone
APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS
| Applicant | Hologic, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, Mar 28, 2008 |
| Received | Oct 4, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072847
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 25, 2009 | Hologic, Inc. Hologic Discovery series Bone Densitometer System
Software versions 12.6, 2.3., or 2.4.
Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a Terminated |
KGI | None listed |
| Aug 25, 2009 | Hologic, Inc. Hologic Explorer series Bone Densitometer System
Software versions 12.6, 2.3., or 2.4.
Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a Terminated |
KGI | None listed |
| Aug 25, 2009 | Hologic, Inc. Hologic QDR 4500 series Bone Densitometer
Software versions 12.6, 2.3., or 2.4
Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a given QDR Terminated |
KGI | None listed |
| Aug 25, 2009 | Hologic, Inc. Hologic Delphi series Bone Densitometer
Software versions 12.6, 2.3., or 2.4
Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a given QDR s Terminated |
KGI | None listed |
| Sep 17, 2008 | Hologic, Inc. Hologic Discovery Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density, comparison of measured variables obtained from a given scan to Terminated |
KGI | None listed |
| Sep 17, 2008 | Hologic, Inc. Hologic QDR4500 Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density, comparison of measured variables obtained from a given scan to Terminated |
KGI | None listed |
| Sep 17, 2008 | Hologic, Inc. Hologic Delphi Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density, comparison of measured variables obtained from a given scan to a Terminated |
KGI | None listed |
| Sep 17, 2008 | Hologic, Inc. Hologic Explorer Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density, comparison of measured variables obtained from a given scan to Terminated |
KGI | None listed |
| Sep 17, 2008 | Hologic, Inc. Hologic Oasis Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density, comparison of measured variables obtained from a given scan to a da Terminated |
KGI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.