DR 800 with Tomosynthesis— 510(k) K183275
Substantially EquivalentAgfa N.V.
FDA 510(k) clearance K183275 for DR 800 with Tomosynthesis, Substantially Equivalent on 2019-02-01. Applicant: Agfa N.V..
Clearance details
- Applicant
- Agfa N.V.
- Product code
- Code IZF
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mortsel, BE
Data sourced from openFDA. This site is unofficial and independent of the FDA.