510(k) K183275 ยท IZF System, X-Ray, Tomographic
DR 800 with Tomosynthesis
| Applicant | Agfa N.V., Mortsel, BE |
| Decision | Substantially Equivalent, Feb 1, 2019 |
| Received | Nov 23, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183275
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 22, 2025 | AGFA Healthcare Corp. Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic
Common Name: DR 800 Open, Classified |
IZF | None listed |
| Aug 27, 2024 | Agfa N.V. DR 800. Digital Radiography X-ray System. Open, Classified |
JAA | None listed |
| Feb 10, 2020 | Agfa N.V. AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize tomographic slices from a single tomographic sweep. Th Terminated |
IZF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.