510(k) K070528 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
PHILIPS ESSENTA DR
| Applicant | Philips Medical Systems GmbH, Dmc, Bothell WA, US |
| Decision | Substantially Equivalent, Mar 9, 2007 |
| Received | Feb 23, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070528
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 27, 2013 | Philips Medical Systems, Inc. Philips Essenta DR, a Stationary x-ray system, X-ray system
Model: 712070
The Essenta DR is a multifunctional stationary X-ray system, in which the swivel arm rotation, the vertical movement of the Terminated |
MQB | None listed |
| Aug 15, 2012 | Philips Healthcare Inc. Philips Essenta DR, X-Ray System, Diagnostic, general-purpose
Model: 712070.
The Essenta DR is a multifunctional stationary X-ray Intended Use From Labeling): system, in which the swivel arm rotation Terminated |
KPR | None listed |
| Oct 6, 2010 | Philips Medical Systems North America Co. Phillips Essenta DR is a digital multifunctional X-ray systems, suitable for all routine radiographic exams, including specialist areas like trauma or pediatric work, excluding mammography.
It is designed for Terminated |
KPR | None listed |
| Sep 16, 2008 | Philips Medical Systems North America Co. Phillips Essenta DR - digital multifunctional x-ray system (application SW release 1.0.2 and lower). The device is intended for routine exams, including specialist areas like trauma or pediatric work, excludi Terminated |
KPR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.