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FDA 510(k)

KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM

K-Number: K110717 · 2011-12-23

ApplicantKonica Minolta Medical & Graphic, Inc.
Decision Date2011-12-23
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Konica Minolta Medical & Graphic, Inc.. It received FDA 510(k) clearance on 2011-12-23 under 510(k) number K110717. The device is classified under product code MUE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM?

KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM is a medical device that received FDA 510(k) clearance on 2011-12-23. The listed applicant is Konica Minolta Medical & Graphic, Inc.. The 510(k) number is K110717.

When did KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM receive FDA 510(k) clearance?

KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM received FDA 510(k) clearance on 2011-12-23, under 510(k) number K110717.

Who is the listed applicant for KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM?

The FDA 510(k) record lists Konica Minolta Medical & Graphic, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM?

The FDA product code for KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM is MUE.

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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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