DR 800 with MUSICA Dynamic— 510(k) K180589
Substantially EquivalentAgfa Healthcare N.V.
FDA 510(k) clearance K180589 for DR 800 with MUSICA Dynamic, Substantially Equivalent on 2018-04-05. Applicant: Agfa Healthcare N.V..
Clearance details
- Applicant
- Agfa Healthcare N.V.
- Product code
- Code JAA
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mortsel, BE
Adverse events under product code JAA
product code JAA- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.