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FDA 510(k)

REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION

K-Number: K051523 · 2005-07-20

ApplicantKonica Minolta Medical & Graphic, Inc.
Decision Date2005-07-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION 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 2005-07-20 under 510(k) number K051523. 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 REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION?

REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION is a medical device that received FDA 510(k) clearance on 2005-07-20. The listed applicant is Konica Minolta Medical & Graphic, Inc.. The 510(k) number is K051523.

When did REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION receive FDA 510(k) clearance?

REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION received FDA 510(k) clearance on 2005-07-20, under 510(k) number K051523.

Who is the listed applicant for REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION?

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 REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION?

The FDA product code for REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION 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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