510(k) K180589 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
DR 800 with MUSICA Dynamic
| Applicant | Agfa Healthcare N.V., Mortsel, BE |
| Decision | Substantially Equivalent, Apr 5, 2018 |
| Received | Mar 6, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180589
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 27, 2024 | Agfa N.V. DR 800. Digital Radiography X-ray System. Open, Classified |
JAA | None listed |
| Apr 6, 2020 | Agfa N.V. AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200 - Product Usage: DR 800: Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoros Terminated |
JAA | None listed |
| Jun 27, 2019 | Agfa N.V. AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic
Product Usage:
The Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) Terminated |
JAA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.