510(k) K102615 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
WIRELESS DR IMAGING OPTION-WDR1
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Nov 18, 2010 |
| Received | Sep 9, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102615
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 24, 2014 | GE Healthcare, LLC GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option (WDR1).
The Wireless DR Imaging Option ( WDR1), when used with a radiographic imaging system, is indict Terminated |
MQB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.