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FDA 510(k)

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

K-Number: K191845 · 2019-09-06

ApplicantBarco N.V.
Decision Date2019-09-06
Product CodePGY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT) is a medical device manufactured by Barco N.V.. It received FDA 510(k) clearance on 2019-09-06 under approval number K191845. The device is classified under product code PGY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT)?

Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT) is a medical device that received FDA 510(k) clearance on 2019-09-06. It is manufactured by Barco N.V.. The 510(k) number is K191845.

When was Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT) approved by the FDA?

Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT) received FDA 510(k) clearance on 2019-09-06, under approval number K191845.

What company makes Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT)?

Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT) is manufactured by Barco N.V..

What is the FDA product code for Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT)?

The FDA product code for Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT) is PGY.

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Related PubMed Literature

PMID: 40972375 AI-based EEG analysis: new technology and the path to clinical adoption. Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology (2025)

Other Devices by Barco N.V.

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Related Devices (Code: PGY)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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