FDA 510(k)

CORONIS FUSION 6MP DL, MODEL: MDCC 6130 DL

K-Number: K073007 · 2008-02-14

ApplicantBarcoview, Medical Imaging Systems

Decision Date2008-02-14

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CORONIS FUSION 6MP DL, MODEL: MDCC 6130 DL is the device name listed in this FDA 510(k) record. The listed applicant is Barcoview, Medical Imaging Systems. It received FDA 510(k) clearance on 2008-02-14 under 510(k) number K073007. 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 6MP DL, MODEL: MDCC 6130 DL?

CORONIS FUSION 6MP DL, MODEL: MDCC 6130 DL is a medical device that received FDA 510(k) clearance on 2008-02-14. The listed applicant is Barcoview, Medical Imaging Systems. The 510(k) number is K073007.

When did CORONIS FUSION 6MP DL, MODEL: MDCC 6130 DL receive FDA 510(k) clearance?

CORONIS FUSION 6MP DL, MODEL: MDCC 6130 DL received FDA 510(k) clearance on 2008-02-14, under 510(k) number K073007.

Who is the listed applicant for CORONIS FUSION 6MP DL, MODEL: MDCC 6130 DL?

The FDA 510(k) record lists Barcoview, Medical Imaging Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORONIS FUSION 6MP DL, MODEL: MDCC 6130 DL?

The FDA product code for CORONIS FUSION 6MP DL, MODEL: MDCC 6130 DL is LLZ.

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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.