510(k) K112670 ยท KPR System, X-Ray, Stationary
DX-D 600
| Applicant | Agfa Healthcare N.V., Greenville SC, US |
| Decision | Substantially Equivalent, Oct 27, 2011 |
| Received | Sep 14, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112670
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 4, 2018 | Agfa-Gevaert, N.V. DX-D 600 DIRECT RADIOGRAPHY SYSTEM
Product Usage:
The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, rad Terminated |
KPR | None listed |
| Sep 25, 2018 | Agfa N.V. DX-D 600
Product Usage:
The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologist Terminated |
KPR | None listed |
| Apr 5, 2017 | AGFA Healthcare Corp. DX-D600 - DXD Imaging Package Terminated |
KPR | None listed |
| Aug 10, 2014 | AGFA Healthcare Corp. DX-D 600 - DXD Imaging Package
Product Usage:Is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to crea Terminated |
KPR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.