510(k) K050704 ยท KPR System, X-Ray, Stationary
MODIFICATION TO: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH IMAGE PASTING AND AUTOPOSITIONING
| Applicant | General Electric Co., Milwaukee WI, US |
| Decision | Substantially Equivalent, Apr 8, 2005 |
| Received | Mar 18, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050704
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | GE Healthcare, LLC GE Healthcare Definium 8000, Digital Radiographic Systems.
Revolution XR/d Digital Radiographic Imaging System with Image Pasting and Autopositioning is indicated for use in generating radiographic Terminated |
KPR | None listed |
| Jan 11, 2012 | GE Healthcare, LLC GE Healthcare Discovery XR650, Digital Radiographic Systems.
Revolution XR/d Digital Radiographic Imaging System with Image Pasting and Autopositioning is indicated for use in generating radiographi Terminated |
KPR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.