OEC OK'ed by FDA to Re-start Production
by Barbara Kram, Editor | April 30, 2008
OEC's 9900 product
line will be
the first to ship
after re-certification
by the FDA
line will be
the first to ship
after re-certification
by the FDA
As a DOTmed registered user, you are the first to get this breaking news: On Thursday, May 1, 2008, GE's OEC unit received notification from the U.S. Food and Drug Administration (FDA) that they have met the requirements under the January 2007 consent decree to resume regular production and distribution operations.
GE further told DOTmed that although OEC is now able to resume regular manufacturing, they cannot ship these systems until the FDA approves their 510(k) request for pre-market clearance. GE expects to receive that shortly, and they are preparing to ship to their customers as soon as possible.
The first product out the door, once full approval is granted, will be the 9900 Elite C-arm.
DOTmed will provide additional updates as we get them.
GE further told DOTmed that although OEC is now able to resume regular manufacturing, they cannot ship these systems until the FDA approves their 510(k) request for pre-market clearance. GE expects to receive that shortly, and they are preparing to ship to their customers as soon as possible.
The first product out the door, once full approval is granted, will be the 9900 Elite C-arm.
DOTmed will provide additional updates as we get them.
