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FDA 510(k)

CORONIS FUSION 10MP, MODEL MDCG-10130

K-Number: K093197 · 2010-06-23

ApplicantBarco N.V.
Decision Date2010-06-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CORONIS FUSION 10MP, MODEL MDCG-10130 is the device name listed in this FDA 510(k) record. The listed applicant is Barco N.V.. It received FDA 510(k) clearance on 2010-06-23 under 510(k) number K093197. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORONIS FUSION 10MP, MODEL MDCG-10130?

CORONIS FUSION 10MP, MODEL MDCG-10130 is a medical device that received FDA 510(k) clearance on 2010-06-23. The listed applicant is Barco N.V.. The 510(k) number is K093197.

When did CORONIS FUSION 10MP, MODEL MDCG-10130 receive FDA 510(k) clearance?

CORONIS FUSION 10MP, MODEL MDCG-10130 received FDA 510(k) clearance on 2010-06-23, under 510(k) number K093197.

Who is the listed applicant for CORONIS FUSION 10MP, MODEL MDCG-10130?

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

What is the FDA product code for CORONIS FUSION 10MP, MODEL MDCG-10130?

The FDA product code for CORONIS FUSION 10MP, MODEL MDCG-10130 is LLZ.

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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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