510(k) K071162 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS
| Applicant | Agfa Healthcare Corp., Greenville SC, US |
| Decision | Substantially Equivalent, May 8, 2007 |
| Received | Apr 26, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071162
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 4, 2011 | AGFA Corp. NX is the radiographer's image identification and quality control tool. It offers a broad array of features developed especially to meet the needs of the radiographer. Standard tasks are completed qui Terminated |
MQB | None listed |
| Jul 26, 2010 | AGFA Corp. 19" Barco MFCD 1219 (Touch Screen) + Low Profile Stand and Rack with LCD Arm
Agfa's Computed Radiography Systems with NX2.X software are indicated for use in providing diagnostic quality images to ai Terminated |
MQB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.