Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT)— 510(k) K191845

Substantially Equivalent

Barco N.V.

FDA 510(k) clearance K191845 for Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT), Substantially Equivalent on 2019-09-06. Applicant: Barco N.V..

Clearance details

Applicant: Barco N.V.
Product code: Code PGY
Advisory panel: Radiology
Date received: 2019-07-10
Decision date: 2019-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kortrijk, BE

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