FDA 510(k)

CORONIS 5MP MAMMO SL, MODEL MDMG 6121

K-Number: K081109 · 2008-05-02

ApplicantBarcoview, Medical Imaging Systems

Decision Date2008-05-02

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CORONIS 5MP MAMMO SL, MODEL MDMG 6121 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 2008-05-02 under 510(k) number K081109. 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 5MP MAMMO SL, MODEL MDMG 6121?

CORONIS 5MP MAMMO SL, MODEL MDMG 6121 is a medical device that received FDA 510(k) clearance on 2008-05-02. The listed applicant is Barcoview, Medical Imaging Systems. The 510(k) number is K081109.

When did CORONIS 5MP MAMMO SL, MODEL MDMG 6121 receive FDA 510(k) clearance?

CORONIS 5MP MAMMO SL, MODEL MDMG 6121 received FDA 510(k) clearance on 2008-05-02, under 510(k) number K081109.

Who is the listed applicant for CORONIS 5MP MAMMO SL, MODEL MDMG 6121?

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 5MP MAMMO SL, MODEL MDMG 6121?

The FDA product code for CORONIS 5MP MAMMO SL, MODEL MDMG 6121 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.