K250947

Substantially Equivalent

VistaSoft 4.0 and VisionX 4.0

Applicant: Durr Dental SE
Product code: QIH
Advisory panel: Radiology
Date received: 2025-03-28
Decision date: 2025-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bietigheim-Bissingen, DE

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.