510(k) K051967 ยท KPR System, X-Ray, Stationary
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS
| Applicant | GE Healthcare, Waukesha WI, US |
| Decision | Substantially Equivalent, Aug 9, 2005 |
| Received | Jul 20, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051967
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 8, 2012 | General Electric Med Systems LLC GE Healthcare Revolution XR/d; GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188
Model numbers: 2259988-2 & 2351505.
The Revolution XR/d Digital Radiographic Imaging System is indicated for u Terminated |
MQB | None listed |
| Feb 21, 2012 | GE Healthcare, LLC REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS
The Revolution XR/d with Tomosynthesis is intended for use in generating Tomographic images of human anatomy. It is not intended Terminated |
KPR | None listed |
| Dec 16, 2009 | GE Medical Systems, LLC GE Healthcare Definium 8000.Model # 5131070.
GE Healthcare, 3000 North Grandview, Waukesha, WI 53188.
The Revolution XR/d with Tomosynthesis is intended for use in generating Tomographic Images of hu Terminated |
KPR | None listed |
| Sep 24, 2009 | GE Medical Systems, LLC Revolution XR/d system control room PC model 5117866-2 with Software collector 5115434 Terminated |
KPR | None listed |
| Sep 22, 2009 | GE Medical Systems, LLC Revolution XR/d systems with control room PC model 5117866-2 with Software collector 5194381. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188.
Intended for use in generating Tomographic image Terminated |
KPR | None listed |
| Sep 25, 2008 | GE Healthcare GE Healthcare Definium 8000 Digital Radiographic System, model number 5135678. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188 U.S.A.
The intended use of this product is to generate tomograp Terminated |
KPR | None listed |
| Sep 25, 2008 | GE Healthcare GE Healthcare Definium 8000 Digital Radiographic System. Terminated |
KPR | None listed |
| Sep 25, 2008 | GE Healthcare GE Healthcare Definium 8000 Digital Radiographic System. Formerly GE Healthcare Revolution XR/d with Tomosynthesis. Terminated |
KPR | None listed |
| Sep 18, 2008 | GE Healthcare GE Definium 8000 , model 5135678, Digital Radiographic Systems. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188, U.S.A. Terminated |
JAA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.