510(k) K103597 ยท IZL System, X-Ray, Mobile
DX-D 100
| Applicant | Agfa Healthcare N.V., Greenville SC, US |
| Decision | Substantially Equivalent, Jan 3, 2011 |
| Received | Dec 8, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103597
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 2, 2024 | Agfa N.V. Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, generator, tube, digital detector, and workstation. This modality is used to generat Open, Classified |
IZL | None listed |
| Mar 29, 2017 | AGFA Healthcare Corp. AGFA Digital Radiography X-Ray System DX-D100
DX-D100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis Terminated |
IZL | None listed |
| Jun 10, 2015 | AGFA Healthcare Corp. AGFA DX-D 100 is a mobile digital radiography x-ray system Terminated |
IZL | None listed |
| Aug 10, 2014 | AGFA Healthcare Corp. Agfa Digital Radiography X-Ray System DX-D 100
Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses. Terminated |
IZL | None listed |
| Jul 21, 2014 | AGFA Corp. AGFA Digital Radiography X-Ray system DX-D 100
Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image Terminated |
IZL | None listed |
| Jun 6, 2013 | AGFA Corp. AGFA Digital Radiography X-Ray System DX-D 100
Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image Terminated |
IZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.