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FDA 510(k)

Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630)

K-Number: K262412 · 2026-10-02

ApplicantBarco NV
Decision Date2026-10-02
Product CodePGY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630) is the device name listed in this FDA 510(k) record. The listed applicant is Barco NV. It received FDA 510(k) clearance on 2026-10-02 under 510(k) number K262412. 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 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630)?

Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630) is a medical device that received FDA 510(k) clearance on 2026-10-02. The listed applicant is Barco NV. The 510(k) number is K262412.

When did Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630) receive FDA 510(k) clearance?

Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630) received FDA 510(k) clearance on 2026-10-02, under 510(k) number K262412.

Who is the listed applicant for Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630)?

The FDA 510(k) record lists Barco NV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630)?

The FDA product code for Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630) is PGY.

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Related Devices (Code: PGY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262985Medical Monitor (32MD08WC)Lg Electronics.IncK262783RadiForce MX247WEizo CorporationK261213Medical Monitor (40HT513D)Lg Electronics.IncK252780LCD Monitor (CL1902A, CL2103F)Shenzhen Beacon Display Technology Co., Ltd.K253242LCD Monitor (C1216W, C822W, C821W)Shenzhen Beacon Display Technology Co., Ltd.K252030RadiForce GX570; RadiForce GX570-AREizo Corporation

Official Source

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

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