510(k) K012389 ยท KPR System, X-Ray, Stationary
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM
| Applicant | Ge Medical Systems, Inc., Milwaukee WI, US |
| Decision | Substantially Equivalent, Aug 10, 2001 |
| Received | Jul 27, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012389
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2014 | GE Healthcare, LLC GE Healthcare, Revolution XR/d.
Revolution XR/d Intended Use: The Revolution XR/d Digital Radiographic imaging system is indicated for use in generating radiographic images of human anatomy. It is i Terminated |
KPR | None listed |
| Jun 8, 2012 | General Electric Med Systems LLC GE Healthcare Definium 8000 Digital Radiographic Systems :
GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188
Model Number: 5131070.
The Revolution XR/d with Tomosynthesis is intended for use Terminated |
MQB | None listed |
| Dec 16, 2009 | GE Medical Systems, LLC GE Healthcare Revolution XR/d. Model #'s 2259988-2 & 2351505.
GE Healthcare, 3000 North Grandview, Waukesha, WI 53188.
The Revolution XR/d Digital Radiographic Imaging System is indicated for use in Terminated |
KPR | None listed |
| Feb 12, 2003 | General Electric Med Systems Revolution XR/d Wall Stand, Model Number 2291655, for Revolution XR/d Digital Radiographic Imaging Systems Terminated |
90L | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.